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¬ÝÀ´¼v¤ù¤~¬Oªø§ë°ò¥»¥\, ¡X¡X×¥¿ ASLAN004 MOA -¼v¤ù aslanpharma.com/drug/aslan004/ 2.Dupilumab MOA -¼v¤ù www.dupixenthcp.com/atopicdermatitis/about/mechanism-of-action MOA www.tsim.org.tw/journal/jour29-6/02.PDF?fbclid=IwAR2B85aLqBUAt5agx6K7u0NkCGTGpr7w6HDCagHhLuu54ZH7FEqHMAdXG3M ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X ¤@¡BII«¬¨üÅé(TYPE II RECEPTER): ¡X¡X¹L±Ó©Êµoª¢¤ÏÀ³ ¸ô®|: ¤»Ó¥D¨¤: °tÅé : (1)IL-4(¤¶¥Õ¯À4¸¹) ,(2)IL-13 (¤¶¥Õ¯À13¸¹) ¨ü¾¹ : (3)IL-4R£\ , (4)IL-13 R£\1 (5)II«¬¨üÅé (TYPE II RECEPTER): (²Õ¦¨ A : IL4 ±µ¦XIL-4R£\ ¦A±µ¦X IL-13 R£\1) (²Õ¦¨ B : IL13 ±µ¦XIL-13R£\1 ¦A±µ¦X IL-4 R£\) (6)pSTAT6 1. IL-4¤ÎIL-13 ¬Ò¥i ³y¦¨¹L±Ó©Êµoª¢¤ÏÀ³ , ¦³¥H¤UA¡BB¨â±ø¸ô®| A: ¥ÑIL-4 ³y¦¨¹L±Ó©Êµoª¢¤ÏÀ³¸ô®| ¸ô®|(1). IL-4 ±µ¦X IL-4R£\ = IL4& IL-4R£\ (2). IL4& IL-4R£\ ¦A±µ¦X IL-13 R£\1=II «¬¨üÅé (²Õ¦¨II«¬ ¨üÅé) (3). II «¬¨üÅé±Ò°Ê²ÓM¤ºªº«H¸¹¶Ç»¼ (4). ¶i¦Ó¬¡¤ÆÂà¿ý¿E¬¡³J¥Õ6 (pSTAT6) (signal transducer and activator of transcription 6, pSTAT6) ¶Ç¾É¸ô®|, (5) ¾ÉP¹L±Ó©Êµoª¢¤ÏÀ³¡C B: ¥ÑIL-13 ³y¦¨¹L±Ó©Êµoª¢¤ÏÀ³¸ô®| ¸ô®|(1). IL-13 ±µ¦X IL-13R£\1 = IL13& IL-13R£\1 (2). IL13 & IL-13R£\1 ¦A±µ¦X IL-4 R£\= II«¬ ¨üÅé (²Õ¦¨II «¬¨üÅé) (3). II «¬¨üÅé ±Ò°Ê²ÓM¤ºªº«H¸¹¶Ç»¼ (4). ¶i¦Ó¬¡¤ÆÂà¿ý¿E¬¡³J¥Õ6 (pSTAT6) (signal transducer and activator of transcription 6, pSTAT6) ¶Ç¾É¸ô®|, (5) ¾ÉP¹L±Ó©Êµoª¢¤ÏÀ³¡C ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X- ¤G丶Dupilumab¤ÎASLAN004 ¬Ò¥i¦P®ÉªýÂ_IL4¤ÎIL13 °T®§¶Ç¾É¸ô®| Dupilumab µ²¦XIL-4R£\ & ASLAN004 µ²¦XIL-13 R£\1¤§¾÷Âà(MOA) ¬Ò¥i¦P®ÉªýÂ_ II«¬¨üÅ餧²Õ¦¨¦ÓÁקKÂà¿ý¿E¬¡³J¥Õ6 (pSTAT6)¤§¬¡¤Æ¡A¤]ÁקK¹L±Ó©Êµoª¢¤ÏÀ³. ¨Ï±oA&B ¸ô®|¤¤¤£²£¥Í(2)~(5)¸ô®|¡C ¤T¡BLebrikizumab & Tralokinumab M〇A , ¥u¯àªýÂ_IL13 °T¸¹¶Ç»¼¡AµLªk§¹¥þªýÂ_IL4 °T¸¹¶Ç»¼¡A¥\¯à¤j´î75%~50%¡C µLªkªýÂ_ A¸ô®| (2): IL4 & IL-4R£\ ¦A±µ¦XIL-13R£\1 , ²Õ¦¨ªºII«¬¨üÅé, ¦]¦Ó±Ò°Ê²ÓM¤ºªº«H¸¹¶Ç»¼¡A¶i¦Ó¬¡¤ÆÂà¿ý¿E¬¡³J¥Õ6 (signal transducer and activator of transcription 6, STAT6) ¶Ç¾É¸ô®|,¾ÉP¹L±Ó©Êµoª¢¤ÏÀ³¡C ¥u¯àªýÂ_B¸ô®| : Lebrikizumab ±µ¦X IL13 ªºB¡BCÁ³±Û , ¦ýIL13 & IL-13R£\1 ¤´¥i±µ¦X¡A¥u¬OµLªk¦A±µ¦X IL-4 R£\,µLªk²Õ¦¨ II«¬ ¨üÅé Tralokinumab ±µ¦XIL13 ªºA¡BDÁ³±Û ¨Ï IL13 & IL-13R£\1 µLªk±µ¦X¡A¤]µLªk¦A±µ¦X IL-4 R£\,µLªk²Õ¦¨ II «¬¨üÅé ¥H¤W¸ÑÄÀ Tralokinumab ¤T´ÁÁ{§É¹w«á«ü¼Ð¡AÀø®Ä´X¥G¥u¦³Dupilumab 50%¡C ¦]Lebrikizumab , IL13 & IL-13R£\1 ¤´¥i±µ¦X¦û¾Ú IL-13R £\1, ¼vÅT0~50% IL4 °T¸¹¶Ç»¼¡C ¤]¸ÑÄÀ Lebrikizumab ¤G´ÁÁ{§É¹w«á¥Dn«ü¼Ð»P¹ï·Ó²Õ¤ñ È ¥u¦³Dupilumab 50%~75% |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/12/17 ¤U¤È 03:37:05²Ä 4991 ½g¦^À³
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Lebrikizumab 2017¦~ ¤w°µ§¹ý³Ý¤T´Á¥¢±Ñ. COPD ¤T´Á¥¢±Ñ. (tralokinumab ý³Ý¤T´Á¦P¼Ë¥¢±Ñ.¦ý¤µ¦~AD¤wÀò¼Ú¬wÃĵý) www.tsim.org.tw/journal/jour29-6/02.PDF?fbclid=IwAR2B85aLqBUAt5agx6K7u0NkCGTGpr7w6HDCagHhLuu54ZH7FEqHMAdXG3M ý³Ý¤T´Á³ø§i¦p¤W. 2017¦~ù¤óROCHE¤~±ÂÅvDERMIRE ¤½¥q¥h°µ¤G´ÁAD. 2017/08/08 (2019/10 ¤T´ÁÁ{§É¶}©l) Dermira¦Vù¤óROCHE ,ÁʶR Lebrikizumab¥þ²yAD¶}µoÅv«eª÷8000¸U¬ü¤¸¡A2018¦~¦A¤ä¥I5500¸U¬ü¤¸¡C ±Ò°Ê²Ä¤@Ó3´Á¤§«e¤ä¥I4000¸U¬ü¤¸¡A¦b¬Y¨Ç¦a°Ï¨ú±oÃÄÃÒ©Mº¦¸°Ó·~¾P°â¨ã¦³¨½µ{¸O·N¸q®É¤ä¥I2.1»õ¬ü¤¸¡A°£¶¡½è©ÊªÍ¯f¥H¥~ªº¾AÀ³¯gªº²b¾P°âÃB¹F¬Y¨Ç»ùȳ̰ª¹F¨ì10.25»õ¬ü¤¸,¦Xp¬ù14»õ¬ü¤¸,¥[¾P°â¤À¼í<= 10%. Áô§t28»õ¬ü¤¸³Ì°ª¾P°âÃB. ©Ò¥HLebrikizumab¥u¥i¥H¥h·mDupilumab AD ¬ù66»õ¥«³õ. 16¶g¤T´Á¤w¹LÃö,¦ý¥¼¤½§G¼Æ¾Ú. ¥t¦³©µ¦ù¨ì52¶gªº¤T´Á©|¦bÁ{§É¤¤. |
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·PÁ¤ѩR¤j¤j «¾ã¦p¤U ¬ü°ê¥Í§Þ¤½¥q Arena Pharmaceuticals(ÁÙ¨S®³¨ìÃÄÃÒ) ªÑ¥»¡G67,000,000ªÑ ¼ìºÅ©Êµ²¸zª¢¬O¤@ºØ¼vÅT¬ü°ê300¸U¤HªººC©Êª¢Äp©Ê¸z¯f ³Ì°ª¾P°âÃB¥i¹F 25»õ¬ü¤¸ Etrasimod ¥¿³B©ó«á´Áªº¬ã¨s¶¥¬q¡AªvÀø®ÄªG±N¤ñ Bristol Myers Squibb(BMY-US) (¦Ê®É¬ü¬I¶QÄ_)ÃļtºX¤Uªº Zeposia §ó¦³®Ä ½÷·ç¦P·N¥H 67»õ¬ü¤¸¦¬ÁÊ¡A´«ºâ¨CªÑ¦¬Áʳø»ù¬° 100 ¬ü¤¸ ·s¥[©Y¥Í§Þ¤½¥q ASLAN Pharmaceuticals(ÁÙ¨S®³¨ìÃÄÃÒ) ªÑ¥»¡G69,663,404ªÑ ²§¦ì©Ê¥Ö½§ª¢¬O¤@ºØ¼vÅT¬ü°ê2,400¸U¤H(¥þ²y¶W¹L2»õ)ªººC©Êª¢¯g ³Ì°ª¾P°âÃB¥i¹F 120»õ¬ü¤¸(Dupilumab) ASLAN004¥¿³B©ó2bÁ{§Éªº¬ã¨s¶¥¬q¡AªvÀø®ÄªG±N¤ñÁÉ¿ÕµáÃļtºX¤UªºDupilumab§ó¦³®Ä (ASLAN004 , ±NÀu©óDupilumab ¤W¥«¼Ð·ÇÀøªk ,2¶g¤@°w300mg~~ASLN¤½¥q²¤¶) clinicaltrials.gov/ct2/show/results/NCT01859988?term=NCT01859988&draw=2&rank=1 Dupilumab AD,2b ªºµ²ªG,¦p¤W XXX¦P·N¥H 000»õ¬ü¤¸¦¬ÁÊ¡A´«ºâ¨CªÑ¦¬Áʳø»ù¬°???¬ü¤¸ ------------------------------------------------------------------------------------------------------------------------------------ ¨È·à±d§@3´Á®É³Q¨ÖÁÊ»ù®æ67»õ¬ü¤¸°_¸õ(¥¼ºâASLAN003¡K¡Kµ¥) |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/12/16 ¤W¤È 11:11:15²Ä 4985 ½g¦^À³
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clinicaltrials.gov/ct2/show/results/NCT01859988?term=NCT01859988&draw=2&rank=1 Dupilumab AD,2b ªºµ²ªG,¦p¤W ASLAN004 , ±NÀu©óDupilumab ¤W¥«¼Ð·ÇÀøªk ,2 ¶g¤@°w300mg,(ASLN¤½¥q²¤¶) |
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ARNA¥«È20´X»õ¬ü¤¸¥«³õªºÃÄ¡A¤T¥|¦~«e ¤w¸g20¥H¤W¤@¸ô©¹¤W¡A¤jº¦¤p¦^ª½¨ì¨ÖÁÊ ¤]´N¬O»¡°µ¤@¡A¤G´Á´N¶}©lº¦¤F¡A¦P¼Ë ©M¦Ñ·à¤@¼Ë¥Rº¡¥¼ª¾ªº·ÀI ¬O¤£¬O¦³¶Â¤â¡A¤£¥i¦Ò¡A¥uª¾¹DªÑ»ù©e©}¤F¡C ¬JµM¤£¦X²z¦ÛµM·|¦^Âk¥¿±` |
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¸ò¨ä¥LAD¥ÎÃĤ@¼Ë¡A2bÁ{§É¸Ñª¼»Ý13Ó¤ë¡A³oÀ³¸Ó¬OIQVIA Biotech¸ò¨È·à±d·¾³q«á³Ì§Ö®É¶¡ÂI¡C ±µ¤U¨Ó¥unÃöª`3Ӯɶ¡ÂI¡G 1.2022¦~Q3ªº´Á¤¤³ø§i¡C 2.2022¦~Q4«D¬ü±ÂÅv¡C 3.2022¦~©³004¥¿¦V¸Ñª¼¡C (003¡Kµ¥³£¬O¨ÖÁʮɽͧPªºÄw½X) (°Ñ¦Ò½÷·ç2021¦~12¤ë14¤é¦¬ÁÊArena Pharmaceuticals¡C¨È·à±d004ªº2bÁ{§É¥¿¦V¸Ñª¼«á¡A§@3´Á®É³Q¨ÖÁÊ»ù67»õ¬üª÷°_¸õ) |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/12/16 ¤W¤È 08:57:23²Ä 4982 ½g¦^À³
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lifesci.rampard.com/WebcastingAppv5/Events/Registration/registration.jsp?Y2lk=MTYxMA==&Y2lk=MTYxMA==&Y2lk=MTYxMA== ²Ä¤G³õ KOL , 2022/01/20 Aslan Pharmaceuticals KOL Webinar Thursday January 20, 2022 at 12:00 PM ET ¼W±jASLAN004 ªº¦¬®×³t«×. |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/12/16 ¤W¤È 08:42:33²Ä 4981 ½g¦^À³
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¤jÃļtªº¤ßºAÀ³¸Ó¬O¹çÄ@ªá100¶R¦³¥Îªº ¤£Ä@ªá10¤¸¶R¨S¥Îªº¡A¤£¥´¨S§â´¤ªº¥M ¦h¤Ö·ÀI¡A´N¦h¤Öªº§ë¸ê n¨ÖÁÊ«Ü¥i¯àn¦Û¤v°µ3b ¦ý¬O¥un2b¼Æ¾ÚÀu¡A¬O¤£¥Î¾á¤ß3b ¶·nªº¸êª÷¡A¤½¥qªºÄw¸ê¯à¤O¤£¥u¤@¦¸®i¥Ü¹L¤F ¥Ø«e2b¹Î¶¤¥H½T©w¡A¤]¤W¸ô¤F ¥«³õÀ³¸Ó·|»EµJ¦b¥¼¨Ó2bªº¼Æ¾Ú¤F ¦pªG¨ì®É¥i§l¤Þ¨ì¤jÃļt¡A©Î¤j«¬§ë¸ê¾÷ºc§ë¸ê ¤@¤Á´N·|¶¶§Q½Âà¡A¼È®ÉÁÙ¬O¥u¯à§Ô§Ô¤F¡A¥[ªo |
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¬üªÑº¦¶^´TµL. ¤p¤½¥q没¿úÅ@½L,Å@½L¥ç«Dªk. ¤p·sÃĤ½¥q¥u¯à¾aÁ{§Éµ²ªG¨Ó¶Ò¸ê,±`±Ä¥]¾P. ¤p·sÃĤ½¥q¥un¯à«ùÄò¶Ò¸ê°µÁ{§É,¸g²z¤H³d¥ô´N¤F. ¤w¦³¥¿±`À禬ªº¤½¥q,¤º³¡¸g²z¤H¤~·|¥ÎÀç¾l¶R®wÂêÑ,´î¤Öµo²{ª÷ªÑ§Q,¥H´î¤Ö¬F©²½Ò²{ª÷µ|,¤S¥i¨ÏªÑ»ù¤jº¦. ¬ü°ê¤½¥qªº¤º³¡¸g²z¤H°tªÑ¬OÁ~¹Sªº¤@¤j³¡¥÷. Àq§J¬O¼ç¦b¨ÖÁʪÌ,¦³»ùȪºASLN,ªÑ»ùÀ£§C,¨ÖÁÊ»ù¤ñ¸û¦n½Í. ²H°¨¿ü¤@¬Ý·sÃĤ£¬O¥L̤p°ê¥i¥Hª±ªº,²£È¬Ò¦b§O°ê. §ï¥H§ë¸êªÌ¬°¥D. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/12/16 ¤W¤È 08:15:26²Ä 4979 ½g¦^À³
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clinicaltrials.gov/ct2/show/NCT05158023?term=aslan004&draw=2&rank=3 2bÁ{§É ¥Dn«ü¼Ð: ¥§¡EASI°´T ,P<0.05 ´N¹LÃö(2b, 4²Õ,¤@©w·|¹LÃö) 2b¥Dn¬Ý ¥¼¨Ó¤T´Á¥Dn«ü¼Ð: (1)IGA 0,1 (2)EASI75, ¬O§_ p<0.001 ¦A¾ÜÀu/©Î¦A³]p,¶i¤J¤T´Á. |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/12/16 ¤W¤È 07:54:29²Ä 4978 ½g¦^À³
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·|û¡G©t¨àÃÄ10140658 µoªí®É¶¡:2021/12/16 ¤W¤È 07:38:37²Ä 4977 ½g¦^À³
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¥¿±`ªº¥«³õ¤ÏÀ³,¬Ý¨ì¬Q¤ÑªºÁ{§É³]p¤½§G,¤@©w·|¤jº¦,¦ý¬°¤°»ò¥u¦³¤pº¦8%,´N¬OX«i¹Î¶¤¥Ç¤U¤£¥i®¾¦^ªº§C¯Å¿ù»~,Åý§ë¸ê¤Hªº°Ñ¦Ò¥u¦³8¶gPÈ¥¼¹F¼Ðªº¦L¶H(¦ÓµLªk·Q¹³16¶g«á«K¦nªº¥i¯à©Ê),§Æ±æ¥¼¨Ó¤jªÑªFÌn¦³¤H¨Ó¨î¤î¤£¾A¥ôªºCEO°µ¥X¤@¨Ç¶Ë®`ªÑ»ùªº¨Æ°Ú!! ·|û¡G©t¨àÃÄ10140658 µoªí®É¶¡:2021/12/15 ¤U¤È 02:48:08²Ä 4969 ½g¦^À³ X«i¹Î¶¤©Ò¥Ç¤Uªº§C¯Å¿ù»~¦p¤U : 1.1B¼Æ¾Ú´¦ÅS004¤£¶·´¦ÅSªº¼Æ¾Ú,¦pEASI-90¤ÎIGA,©úª¾¼Ë¥»¼Æ¹L¤Ö®£¥¢¯u,¤´°õ·N¤½¥¬,¥«³õ¤H¤h¤£¶R³æ,¨Æ«á¸ÑÄÀ§ó¬OµL¥Î,P¤j¤á«ùªÑÄY«ÃP°Ê,¯u¬O¥v¤W³Ì§C¯Åªº¿ù»~~~¦³³oºØCEO¯u¥¿Ë·°... 2.¦³¨Æ¨S¨Æ´N¨ì¦UºØ§ë¸êConference§i¶D¾÷ºcªk¤H§Ú¦³¦h¯Ê¿ú(¤j®a¦³µLµo²{,¥unX«i°Ñ¥[§¹§ë¸ê·|ij,ªÑ»ù´N¤U¶^,µM¨ä¹ê¤âÀY¸êª÷ÁÙ°÷¥Î¨ì2023¦~)~~ ¥H¤WÆ[¹î,¨Ñ°Ñ¦Ò °J¤ß§Æ±æMERCK¤Î²H°¨¿ü¤jªÑªF¥X½u¼µ°_¨È·à±d~~~ |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/12/16 ¤W¤È 07:15:33²Ä 4976 ½g¦^À³
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ASLAN004 AD,2bÁ{§Éªº5组¡A°w¾¯¬I¥´´Á¤Î°w¾¯¶q³W¹º¡A¦p¤U clinicaltrials.gov/ct2/show/NCT05158023?term=aslan004&draw=2&rank=3 1.¦w衞¾¯组 0,1,3,5,7,9,11,13¡A15¶g¦U¤@°w¡C 2.ASLAN004 ,300mg组¡AQ2W(2¶g¤@°w) 0,1,3,5,7,9,11,13¡A15¶g¦U¤@°w¡A¦Xp2700mg 3.ASLAN004,400mg组¡AQ2W(2¶g¤@°w) 0,1,3,5,7,9,11,13¡A15¶g¦U¤@°w¡A¦Xp3600mg 4.ASLAN004,400mg组¡AQ4W(¥|¶g¤@°w) 0,1,2,6,10,14¶g¦U¤@°w¡A¦Xp2400mg 4,8,12¶g¡A¦U¤@°w¦w衞¾¯¡C 5,ASLAN004,600mg组¡AQ4W(¥|¶g¤@°w) 0,1,2,6,10,14¶g¡A¦U¤@°w¡A¦Up3600mg 4,8,12¶g¡A¦U¤@°w¦w衞¾¯¡A |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/12/15 ¤U¤È 09:04:22²Ä 4975 ½g¦^À³
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ASLAN004 2bÁ{§É ¤µ¤Ñ¶}©l¡A¸Ñª¼¹wp¤é´Á¡G©ú¦~©³ Phase 2b Study of Efficacy and Safety of ASLAN004 in Adults With Moderate-to-Severe Atopic Dermatitis clinicaltrials.gov/ct2/show/NCT05158023?term=Aslan004&draw=2&rank=3 Study Design Go to sections Study Type : Interventional (Clinical Trial) Estimated Enrollment : 295 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Adult Patients With Moderate-to-Severe Atopic Dermatitis Estimated Study Start Date : December 31, 2021 Estimated Primary Completion Date : December 15, 2022 Estimated Study Completion Date : April 15, 2023 |
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·|û¡G³¯¤p©ú10152293 µoªí®É¶¡:2021/12/15 ¤U¤È 06:22:36²Ä 4974 ½g¦^À³
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©t¨àÃĤj 004 1bµL»Ý¤½¥¬ªº¼Æ¾Ú µw¬O¤½¥¬¡A³y¦¨ªÑ»ù¤j¶^ §Ú¦X²zÃhºÃ¡A³Åx©ñªÅ¨È·à±d |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/12/15 ¤U¤È 05:46:49²Ä 4973 ½g¦^À³
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ir.aslanpharma.com/static-files/46bd8803-de3d-49ee-8aee-7830141d11b7 P.29 Åé¥~¬ã¨sªí©ú ASLAN003 ¨ã¦³ 6 ºØ¤wÀò§å㪺Á{§É¶¥¬q DHODH §í»s¾¯ , ¨x¬r©Êªº¥i¯à©Ê³Ì§C ---------------------------- ¨x¬r©Ê§C®t1¿¥ª¥k.ASLAN003¥ÎÃÄ¥i¥[¶q,¥i¥[³t½w¸Ñ. In vitro studies demonstrated ASLAN003 has lowest potential for hepatotoxicity out of 6 approved and clinical stage DHODH inhibitors |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/12/15 ¤U¤È 05:31:52²Ä 4972 ½g¦^À³
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ASLAN003 ½w¸Ñ®Ä²v Àu©ó IMU-838,¤§«e¦³¤ñ¸û¹L. ------------------------------------------------------ DGAP-·s»D¡GImmunic, Inc. «Å§G¦b´_µo©Ê¦hµo©Êµw¤Æ¯gªº vidofludimus ¶t (IMU-838) ENSURE 3 ´Á¶µ¥Ø¤¤©Û¶Ò²Ä¤@¦ì±wªÌ µo§G®É¶¡¡G2021 ¦~ 11 ¤ë 18 ¤é¤U¤È 4:01 ET MarketWatch ·s»D³¡¥¼°Ñ»P¦¹¤º®eªº³Ð«Ø¡C DGAP-·s»D¡GImmunic, Inc. / ÃöÁäµü¡G¬ã¨s Immunic, Inc. «Å§G¦b´_µo©Ê¦hµo©Êµw¤Æ¯gªº vidofludimus ¶t (IMU-838) ENSURE 3 ´Á ENSURE p¹º¤¤©Û¶Ò²Ä¤@¦ì±wªÌ 18.11.2021 / 22:01 µo¦æ¤H¹ï¥»¤½§iªº¤º®et¥þ³¡³d¥ô¡C 18.11.2021 ¶Ç¼½¥Ñ DGAP ¶Ç¿éªº¥ø·~·s»D - EQS Group AG ªº¤@¶µªA°È¡C µo¦æ¤H¹ï¥»¤½§iªº¤º®et¥þ³¡³d¥ô¡C DGAP-News: Immunic, Inc. Announces Enrollment of First Patient in its Phase 3 ENSURE Program of vidofludimus calcium (IMU-838) in Relapsing Multiple Sclerosis The MarketWatch News Department was not involved in the creation of this content. DGAP-News: Immunic, Inc. / Key word(s): Study Immunic, Inc. Announces Enrollment of First Patient in its Phase 3 ENSURE Program of vidofludimus calcium (IMU-838) in Relapsing Multiple Sclerosis 18.11.2021 / 22:01 The issuer is solely responsible for the content of this announcement. 18.11.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement. The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de |
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·|û¡G¸Ø±i10133098 µoªí®É¶¡:2021/12/15 ¤U¤È 05:22:36²Ä 4971 ½g¦^À³
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¬ü°ê¥Í§Þ¤½¥q Arena Pharmaceuticals(ÁÙ¨S®³¨ìÃÄÃÒ) ªÑ¥»¡G67,000,000ªÑ ¼ìºÅ©Êµ²¸zª¢¬O¤@ºØ¼vÅT¬ü°ê300¸U¤HªººC©Êª¢Äp©Ê¸z¯f ³Ì°ª¾P°âÃB¥i¹F 25»õ¬ü¤¸ Etrasimod ¥¿³B©ó«á´Áªº¬ã¨s¶¥¬q¡AªvÀø®ÄªG±N¤ñ Bristol Myers Squibb(BMY-US) (¦Ê®É¬ü¬I¶QÄ_)ÃļtºX¤Uªº Zeposia §ó¦³®Ä ½÷·ç¦P·N¥H 67»õ¬ü¤¸¦¬ÁÊ¡A´«ºâ¨CªÑ¦¬Áʳø»ù¬° 100 ¬ü¤¸ ·s¥[©Y¥Í§Þ¤½¥q ASLAN Pharmaceuticals(ÁÙ¨S®³¨ìÃÄÃÒ) ªÑ¥»¡G69,663,404ªÑ ²§¦ì©Ê¥Ö½§ª¢¬O¤@ºØ¼vÅT¬ü°ê2,400¸U¤H(¥þ²y¶W¹L2»õ)ªººC©Êª¢¯g ³Ì°ª¾P°âÃB¥i¹F 120»õ¬ü¤¸(§ùÁת¢) 004¥¿³B©ó2bÁ{§Éªº¬ã¨s¶¥¬q¡AªvÀø®ÄªG±N¤ñÁÉ¿ÕµáÃļtºX¤Uªº§ùÁת¢§ó¦³®Ä ¦A¥[¤W 003±N¶i¦æ2bÁ{§Éªº¬ã¨s¶¥¬q¡A¥B§@¥Î¾÷Âà¥ÑImmunic, Inc. ªºÃĪ«( IMU-838 )ÃÒ©ú¤F¡C XXX¦P·N¥H 000»õ¬ü¤¸¦¬ÁÊ¡A´«ºâ¨CªÑ¦¬Áʳø»ù¬°???¬ü¤¸ ------------------------------------------------------------------------------------------------------------------------------------ §Úı±o¦¬Áʨȷà±d»ù®æÀ³¸Ó¯}100»õ¬ü¤¸¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/12/15 ¤U¤È 04:32:46²Ä 4970 ½g¦^À³
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©MASLAN003 ¬Û¦P¾÷Âà(³q¹LªýÂ_¤G²B¨Å²M»Ä²æ²B酶 (DHODH))ªºIMU-838 Immunic, Inc. «Å¥¬§¹¦¨ IMU-838 ªvÀø¤¤«×¦Ü««×¼ìºÅ©Êµ²¸zª¢ªº CALDOSE-1 2 ´Á¸ÕÅ窺µù¥U - ¹wp 2022 ¦~²Ä¤G©u«×ªº³»½u¼Æ¾Ú - clinicaltrials.gov/ct2/show/NCT03341962?term=NCT03341962&draw=2&rank=1 Ãö©ó IMU-838 IMU-838 ¬O¤@ºØ¥i¤fªAªº¤U¤@¥N¿ï¾Ü©Ê§K¬Ì½Õ¸`¾¯¡A³q¹LªýÂ_¤G²B¨Å²M»Ä²æ²B酶 (DHODH) ¨Ó§í¨î¬¡¤Æ§K¬Ì²ÓMªº²ÓM¤º¥NÁ¡C IMU-838 §@¥Î©ó¬¡¤Æªº T ²ÓM©M B ²ÓM¡A¦P®É¨Ï¨ä¥L§K¬Ì²ÓM°ò¥»¤£¨ü¼vÅT¡A¨Ã¤¹³\§K¬Ì¨t²Î«O«ù¥\¯à¡A¨Ò¦p¹ï§Ü·P¬V¡C¦b¤§«eªº¸ÕÅ礤¡A»P¦w¼¢¾¯¬Û¤ñ¡AIMU-838 ¨S¦³Åã¥Ü·P¬V²v¼W¥[¡C¦¹¥~¡A¤wª¾ DHODH §í»s¾¯¡]¦p IMU-838¡^¨ã¦³°ò©ó±J¥Dªº§Ü¯f¬r§@¥Î¡A³oºØ§@¥Î»P¯S©w¯f¬r³J¥Õ¤Î¨äµ²ºcµLÃö¡C¦]¦¹¡ADHODH§í¨î¥i¯à¼sªx¾A¥Î©ó¦hºØ¯f¬r¡CIMU-838 ©ó 2017 ¦~¦b¨â¶µ 1 ´ÁÁ{§É¸ÕÅ礤¦¨¥\´ú¸Õ¡A¥Ø«e¥¿¦b¼ìºÅ©Êµ²¸zª¢±wªÌªº 2 ´Á¸ÕÅ礤¶i¦æ´ú¸Õ¡C 2020 ¦~²Ä¤T©u«×¡A¸Ó¤½¥q³ø§i¤F IMU-838 ªvÀø´_µo½w¸Ñ«¬¦hµo©Êµw¤Æ¯gªº EMPhASIS 2 ´Á¸ÕÅ窺¿n·¥µ²ªG¡A¹ê²{¤F¨ã¦³°ª«×²ÎpÅãµÛ©Êªº¥Dn©MÃöÁ䦸n²×ÂI¡C 2021 ¦~²Ä¤@©u«×¡AImmunic «Å¥¬ IMU-838¦b¨ä°w¹ï¤¤«× COVID-19¦í°|±wªÌªº CALVID-1 2´Á¸ÕÅ礤Åã¥Ü¥XÁ{§É¬¡©ÊªºÃÒ¾Ú¡C¦¹¥~¡A¦b 2021 ¦~²Ä¤@©u«×¡A¸Ó¤½¥q³ø§i¤F»P±ö¶ø¶E©Ò¦X§@¶i¦æªº IMU-838ªvÀøìµo©Êµw¤Æ©ÊÁxºÞª¢ªº²Ä 2 ´Á·§©ÀÅçÃÒÁ{§É¸ÕÅ窺¿n·¥³»½u¼Æ¾Ú¡C¨´¤µ¬°¤î¡AIMU-838 ¤w¦b 800 ¦hÓÓÅ餤¶i¦æ¤F´ú¸Õ¡A¨ÃÅã¥Ü¥X¦³§l¤Þ¤OªºÃÄ¥N°Ê¤O¾Ç¡B¦w¥þ©Ê©M@¨ü©Ê¯S¼x¡C IMU-838 ©|¥¼¦b¥ô¦ó°ê®a/¦a°ÏÀò±o³\¥i©Î§åã¡C www-prnewswire-com.translate.goog/news-releases/immunic-inc-announces-completion-of-enrollment-of-its-phase-2-caldose-1-trial-of-imu-838-in-moderate-to-severe-ulcerative-colitis-301410732.html?_x_tr_sl=en&_x_tr_tl=zh-TW&_x_tr_hl=zh-TW&_x_tr_pto=sc Immunic, Inc. 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IQVIA ¥Ø«e¬O¥@¬É¤W³Ì¤jªº CRO¡A2018 ¦~ªº¦¬¤J¬° 104 »õ¬ü¤¸ 2018 ¦~¥þ²y CRO ¥«³õ»ùȹF¨ì 390 »õ¬ü¤¸¡A¹wp¨ì 2021 ¦~±N¶W¹L 440 »õ¬ü¤¸¡A¦]¬°±M§Q¨ì´Á¡B¥é»sÃÄ¿E¼W¥H¤Î²¾°ÊÂåÀø©M¤j¼Æ¾Úµ¥§Þ³N³Ð·s¼vÅT²£«~¶}µo¡A©Ò¦³³o¨Ç³£¾ÉP§ó¦hªº¤u§@¥~¥]µ¹ CRO¡C The global CRO market value reached $39 billion in 2018 and is expected to exceed $44 billion by 2021, as patent expiration, proliferation of generic medications, and technological innovations like mHealth and big data influence product development all leading to greater outsourcing of work to CROs. The company adopted the name IQVIA in 2017 following the merger of Quintiles and information and technology group IMS, which offers their clients an end-to-end clinical and commercial service. It is currently the largest CRO in the world, with a $10.4 billion revenue in 2018. After a string of further acquisitions of smaller specialist companies, the company is going from strength to strength and are truly at the forefront of the CRO world. This is particularly true in the real-world evidence and data space. Currently the services they provide are unparalleled by other leading CROs but it is worth watching how IQVIA will navigate emerging key drivers of the industry, such as digital health and artificial intelligence. ¦b©ø®õ»P«H®§©M§Þ³N¶°¹Î IMS ¦X¨Ö«á¡A¸Ó¤½¥q©ó 2017 ¦~±Ä¥Î¤F IQVIA ªº¦WºÙ¡A«áªÌ¬°«È¤á´£¨ÑºÝ¨ìºÝªºÁ{§É©M°Ó·~ªA°È¡C ¥¦¥Ø«e¬O¥@¬É¤W³Ì¤jªº CRO¡A2018 ¦~ªº¦¬¤J¬° 104 »õ¬ü¤¸¡C ¦b¹ï¸û¤pªº±M·~¤½¥q¶i¦æ¤@¨t¦C¶i¤@¨B¦¬Áʤ§«á¡A¸Ó¤½¥q¥¿¦b¤£Â_§§¤j¡A¯u¥¿¨«¦b CRO ¥@¬Éªº«e¦C¡C ¦b²{¹ê¥@¬ÉªºÃÒ¾Ú©M¼Æ¾ÚªÅ¶¡¤¤¤×¨ä¦p¦¹¡C ¥Ø«e¡A¥LÌ´£¨ÑªºªA°È¬O¨ä¥L»â¥ý CRO ©ÒµLªk¤ñÀÀªº¡A¦ýȱoÃöª` IQVIA ±N¦p¦ó¾r¶¿¸Ó¦æ·~ªº·s¿³ÃöÁäÅX°Ê¦]¯À¡A¨Ò¦p¼Æ¦r°·±d©M¤H¤u´¼¯à¡C www.proclinical.com/blogs/2019-5/top-10-contract-research-organisations-cros-to-watch-in-2019 |
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IBD¥«³õ 4.80% (¦~¼W²v) ¦~ »õ¬ü¤¸ 2021 200 2022 210 2023 220 2024 230 2025 242 2026 253 2027 265 2028 278 The global inflammatory bowel disease treatment market size is expected to reach USD 27.8 billion by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 4.8% from 2021 to 2028 ®Ú¾Ú Grand View Research, Inc. ªº¤@¥÷·s³ø§i¡A¨ì 2028 ¦~¡A¥þ²yª¢¯g©Ê¸z¯f(IBD)ªvÀø¥«³õ³W¼Ò¹wp±N¹F¨ì 278 »õ¬ü¤¸¡C¸Ó¥«³õ¹wp±q 2021 ¦~¨ì 2028 ¦~±N¥H 4.8% ªº½Æ¦X¦~¼Wªø²v¼Wªø |
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View printer-friendly version << Back Dec 06,2021 ASLAN Pharmaceuticals and IQVIA Biotech Enter Into Strategic Collaboration MENLO PARK, Calif. and SINGAPORE, Dec. 06, 2021 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq: ASLN), a clinical-stage, immunology-focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced the appointment of IQVIA Biotech, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, as its preferred clinical research organization for logistics related to decentralized clinical trials, including the global oversight, expansion and engagement of patients for trials related to the clinical development of ASLAN004 and ASLAN003. IQVIA Biotech will provide patient recruitment, clinical monitoring, medical writing and biostatistics for ASLAN¡¦s upcoming 300-patient Phase 2b trial of ASLAN004 in adults with moderate-to-severe atopic dermatitis. IQVIA Biotech will work closely with ASLAN¡¦s management to oversee clinical operations and the recruitment of patients across sites in the United States, Canada, Europe and Asia. IQVIA Biotech is also positioned to collaborate with ASLAN¡¦s clinical operations team on the future development plans for ASLAN003 in inflammatory bowel disease (IBD), with clinical trials commencing early next year. Enrollment of the first patient in the ASLAN004 Phase 2b trial is expected in the fourth quarter of 2021. Senthil Sockalingam, Head, IQVIA Biotech Japan and Asia Pacific, commented, ¡§We are delighted to collaborate with ASLAN on the clinical development of ASLAN003 and ASLAN004 at this exciting and critical juncture, following the successful proof-of-concept study for ASLAN004 in atopic dermatitis. Emerging biopharma companies represent a significant portion of innovation in life sciences, and their needs are nuanced. IQVIA Biotech is focused on solutions for emerging biopharma, and, with the launch of IQVIA Biotech JAPAC (Japan and Asia Pacific), will look forward to providing ASLAN with a top-tier team to deliver on its clinical milestones.¡¨ Stephen Doyle, Chief Business Officer, ASLAN Pharmaceuticals, commented, ¡§We look forward to partnering with IQVIA Biotech as we undertake the late-stage clinical development of ASLAN004. We believe that we have identified a team with a strong reputation and commercial strategy, as well as a wide network of scientific experts with deep experience running dermatology studies to complement the clinical and medical capabilities ASLAN has built internally. Given the number of studies that IQVIA Biotech is conducting in atopic dermatitis, we are confident it can leverage its network of relationships to deliver increased efficiencies in patient recruitment for our upcoming studies.¡¨ Media and IR contacts ir.aslanpharma.com/news-releases/news-release-details/aslan-pharmaceuticals-and-iqvia-biotech-enter-strategic 2021 ¦~ 12 ¤ë 6 ¤é ªü´µÄõ»sÃÄ»P IQVIA Biotech ¹F¦¨¾Ô²¤¦X§@ ¥[§QºÖ¥§¨È¦{ªù¬¥©¬§J©M·s¥[©Y¡A2021 ¦~ 12 ¤ë 6 ¤é¡]¥þ²y·s»D³q°TªÀ¡^¡X¡XASLAN Pharmaceuticals¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GASLN¡^¬O¤@®aÁ{§É¶¥¬q¡B±Mª`©ó§K¬Ì¾Çªº¥Íª«»sÃĤ½¥q¡A¶}µo³Ð·sÀøªk¥H§ïÅܱwªÌªº¥Í¬¡¡A¤µ¤Ñ«Å¥¬¥ô©R IQVIA Biotech¡A¤@®a¬°¥Í©R¬ì¾Ç¦æ·~´£¨Ñ¥ý¶i¤ÀªR¡B§Þ³N¸Ñ¨M¤è®×©MÁ{§É¬ã¨sªA°Èªº¥þ²y»â¥ý¨ÑÀ³°Ó¡A§@¬°¨äº¿ïªºÁ{§É¬ã¨s²Õ´¡A¥Î©ó»P¤À´²Á{§É¸ÕÅç¬ÛÃöªºª«¬y¡A¥]¬A¥þ²yºÊ·þ¡BÂX®i©M±wªÌ°Ñ»P¥Î©ó»P ASLAN004 ©M ASLAN003 Á{§É¶}µo¬ÛÃöªº¸ÕÅç¡C IQVIA Biotech ±N¬° ASLAN §Y±N¦b±w¦³¤¤«×¦Ü««×¯SÀ³©Ê¥Öª¢ªº¦¨¤H¤¤¶i¦æªº ASLAN004 300 ¦W±wªÌ 2b ´Á¸ÕÅç´£¨Ñ±wªÌ©Û¶Ò¡BÁ{§ÉºÊ´ú¡BÂå¾Ç¼g§@©M¥Íª«²Îp¾Ç¡C IQVIA Biotech ±N»P ASLAN ªººÞ²z¼h±K¤Á¦X§@¡A¥HºÊ·þ¬ü°ê¡B¥[®³¤j¡B¼Ú¬w©M¨È¬w¦U¦aªºÁ{§É¹BÀç©M±wªÌ©Û¶Ò¡C IQVIA Biotech ÁٷdzƻP ASLAN ªºÁ{§É¹BÀç¹Î¶¤´N ASLAN003¦bª¢¯g©Ê¸z¯f (IBD) ¤¤ªº¥¼¨Ó¶}µop¹º¶i¦æ¦X§@¡AÁ{§É¸ÕÅç±N©ó©ú¦~ªì¶}©l¡C ASLAN004 2b ´Á¸ÕÅ窺²Ä¤@¦ì±wªÌ¹wp±N©ó 2021 ¦~²Ä¥|©u«×¤J²Õ¡C IQVIA Biotech ¤é¥»©M¨È¤Ó°Ït³d¤H Senthil Sockalingam µû½×¹D¡G¡§Ä~ ASLAN004 ¥Î©ó¯SÀ³©Êªº·§©ÀÅçÃÒ¬ã¨s¦¨¥\¤§«á¡A§ÚÌ«Ü°ª¿³¦b³oÓ¿E°Ê¤H¤ßªºÃöÁä®É¨è»P ASLAN ¦X§@¶i¦æ ASLAN003 ©M ASLAN004 ªºÁ{§É¶}µo¥Öª¢¡C·s¿³ªº¥Íª«»sÃĤ½¥q¥Nªí¤F¥Í©R¬ì¾Ç³Ð·sªº«n²Õ¦¨³¡¤À¡A¥¦Ìªº»Ý¨D¬O²Ó·Lªº¡C IQVIA Biotech ±Mª`©ó·s¿³¥Íª«»sÃĪº¸Ñ¨M¤è®×¡AÀHµÛ IQVIA Biotech JAPAC¡]¤é¥»©M¨È¤Ó¦a°Ï¡^ªº±À¥X¡A±N´Á«Ý¬° ASLAN ´£¨Ñ¤@¬yªº¹Î¶¤¡A¥H¹ê²{¨äÁ{§É¨½µ{¸O¡C¡¨ ASLAN Pharmaceuticals º®u°Ó°È©x Stephen Doyle µû½×¹D¡G¡§§ÚÌ´Á«Ý»P IQVIA Biotech ¦X§@¡A¦@¦P©Ó¾á ASLAN004ªº«á´ÁÁ{§É¶}µo¡C§Ú̬۫H¡A§Ṳ́w¸g½T©w¤F¤@Ө㦳¨}¦nÁnÅA©M°Ó·~¾Ô²¤ªº¹Î¶¤¡A¥H¤Î¾Ö¦³Â×´Iªº¥Ö½§¯f¾Ç¬ã¨s¸gÅ窺¼sªx¬ì¾Ç±M®aºôµ¸¡A¥H¸É¥R ASLAN ¤º³¡«Ø¥ßªºÁ{§É©MÂåÀø¯à¤O¡CŲ©ó IQVIA Biotech ¥¿¦b¶i¦æªº¯SÀ³©Ê¥Öª¢¬ã¨sªº¼Æ¶q¡A§Ú̬۫H¥¦¥i¥H§Q¥Î¨äÃö«Yºôµ¸¬°§Ú̧Y±N¶i¦æªº¬ã¨s´£°ª±wªÌ©Û¶Ò®Ä²v¡C¡¨ ´CÅé©M§ë¸êªÌÃö«YÁpô¤H |
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July 9, 2014 at 5:00 PM EDT Back REGENERON AND SANOFI ANNOUNCE POSITIVE RESULTS FROM PHASE 2B STUDY OF DUPILUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS TARRYTOWN, N.Y. and PARIS, July 9, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (EURONEXT: SAN and NYSE: SNY) today announced positive results from a Phase 2b dose-ranging study of dupilumab, an investigational therapy, in adult patients with moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema. All doses of dupilumab met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared to placebo. In addition, the companies also announced that four earlier clinical studies of dupilumab in moderate-to-severe atopic dermatitis were published today in the New England Journal of Medicine (NEJM). Dupilumab is an investigational monoclonal antibody that blocks signaling of IL-4 and IL-13, two cytokines that play a key role in the pathogenesis of moderate-to-severe atopic dermatitis. These clinical data, coupled with our phase 2a results in asthma last year, support the growing scientific evidence that the IL-4/IL-13 pathway may be a fundamental driver in allergic diseases, said George D. Yancopoulos, M.D., Ph. D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. Blocking IL-4/IL-13 signaling may provide an important new approach to atopic conditions, including asthma, atopic dermatitis and nasal polyposis, where we have ongoing clinical programs. In the Phase 2b trial, all five subcutaneous doses of dupilumab showed a dose-dependent improvement in the primary endpoint, the mean percent change in EASI score from baseline to week 16. The improvements in EASI score ranged from a high of 74 percent for patients in the highest dose group, who received 300 milligrams (mg) weekly, to a low of 45 percent in patients who received the lowest dose of 100 mg monthly, compared to 18 percent for patients in the placebo group (p < 0.0001 for all doses). The most common adverse event (AE) in the Phase 2b study was nasopharyngitis, which was balanced across dupilumab treatment groups (18.5 to 23 percent) compared to placebo (21 percent). Injection site reactions were more frequent in the dupilumab group (5 to 9.5 percent) compared to placebo (3 percent), as was headache (12 to 15 percent) compared to placebo (8 percent). Dupilumab-treated patients showed highly statistically significant and dose-dependent improvements in additional key efficacy measures compared to placebo after 16 weeks of treatment: 12 percent to 33 percent of dupilumab-treated patients achieved clearing or near-clearing of skin lesions, as measured by an investigator¡¦s global assessment (IGA) score of 0 or 1, compared to 2 percent with placebo. (p=0.02 to p < 0.0001) Dupilumab-treated patients experienced a 16.5 percent to 47 percent mean reduction in itching, as measured by the pruritus numerical-rating scale (NRS) score, compared to an increase of 5 percent in the placebo group. (p=0.0005 to p < 0.0001) Atopic dermatitis is known to have a profoundly negative effect on quality of life and people with more severe forms of this disease have limited therapeutic choices, said Elias Zerhouni, M.D., President, Global R&D, Sanofi. These latest results are consistent with what was observed in the earlier clinical studies and add to the body of evidence that investigational dupilumab may have a role to play for patients with moderate-to-severe atopic dermatitis. We are now able to select the optimal doses for the phase 3 studies, which we anticipate to begin later this year. This Phase 2b double-blind, placebo-controlled, 16-week, dose-ranging study randomized 380 patients with moderate-to-severe atopic dermatitis, who could not be adequately controlled with topical medication or for whom topical treatment was not advisable. Patients were randomized to receive one of five doses of dupilumab (300 mg weekly, 300 mg every other week, 300 mg monthly, 200 mg every other week, 100 mg monthly) or placebo. Patients in the study had approximately 50 percent of their skin affected by atopic dermatitis at baseline. Within the past year, approximately 35 percent of patients received an oral corticosteroid and approximately 20 percent received a systemic non-steroid immunosuppressant for AD. Approximately 60 percent of patients had another allergic condition, including approximately 40 percent of patients who had a history of asthma. The follow-up period of the study is ongoing and patients will be followed for 16 weeks after treatment. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/19 ¤U¤È 06:41:44²Ä 4907 ½g¦^À³
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2020/01 19¬ü¤¸/ªÑ,(11»õ¬ü¤¸) ³QLily¨ÖÁÊ www.investing.com/equities/dermira |
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·|û¡G¸Ø±i10133098 µoªí®É¶¡:2021/11/19 ¤U¤È 05:22:14²Ä 4906 ½g¦^À³
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lebrikizumab ,2018/02¶}©l2b ADÁ{§É, ·í®ÉªÑ»ù8¬ü¤¸/ªÑ. 2019/03 2¤ëAD¸Ñª¼¦¨¥\12¬ü¤¸ 2020/01 19¬ü¤¸³QLily¨ÖÁÊ(11»õ¬ü¤¸) ------------------- ½Ð°Ý11»õ¬ü¤¸´«ºâ¦¨ªÑ»ù¬O¦h¤Ö? |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/19 ¤U¤È 12:42:12²Ä 4905 ½g¦^À³
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CNTB: ²Ä¤@¤j·ÀI: ¦~©³³Q¬ü°êµý´Á·|¤U¥«. ²Ä¤G¤j·ÀI : CPB201¥i¯àÃø¦b2031¦~«eµLªk¦b¼Ú¬ü¤W¥«,©MREGN ¦]§@¥ÎÂI¬Û¦P¦s¦b¼ç¦b±M§Q©x¥q. ASLAN µL¥H¤W¶¡ÃD. ¬Ý¤@¤ULebrikizumabªºDERM ªº½u«¬. ³Q¨ÖÁÊ«e¤TÓ¤ë(2019/08) ¶^¨ì5.5¬ü¤¸,³Ì«á19¬ü¤¸³Q¨ÖÁÊ(2020/01). lebrikizumab ,2018/02¶}©l2b ADÁ{§É, ·í®ÉªÑ»ù8¬ü¤¸/ªÑ. 2019/03 2¤ëAD¸Ñª¼¦¨¥\12¬ü¤¸ 2020/01 19¬ü¤¸³QLily¨ÖÁÊ(11»õ¬ü¤¸) ------------------------- www.investing.com/equities/dermira |
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·|û¡G¤p¾ð10027223 µoªí®É¶¡:2021/11/19 ¤W¤È 11:59:36²Ä 4904 ½g¦^À³
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CNTB: CBP-201 ¤G´Á ¤¤-««×AD: ¥Ø«e½L«á¤j¶^25%¡A¶^¦Ü9¬ü¤¸¡C8¤ë³Ì°ª29¬ü¤¸/ªÑ,¤w¤j¶^70%. ³o¤j¶^ªº·Pı¦n¼ô±x,«Ü¹³¦Ñ·àªº¶^¶Õ? ¤½¥q³£¦Û»{¼Æ¾Ú«Ü¦n,¦ý§O¤H´N¬O¤£¶R³æ! |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/19 ¤W¤È 11:09:20²Ä 4903 ½g¦^À³
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clinicaltrials.gov/ct2/show/results/NCT01859988?term=NCT01859988&draw=2&rank=1 Dupilumab 2b AD Á{§É,¤À¤»²Õ(N=61~65¤H/²Õ) µ²ªG,¦p¤W Dupilumab 300 mg qw Dupilumab 300 mg q2w Dupilumab 200 mg q2w Dupilumab 300 mg q4w Dupilumab 100 mg q4w Placebo |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/19 ¤W¤È 10:30:08²Ä 4902 ½g¦^À³
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The Company intends to hold a conference call to discuss the detailed trial results from this global Phase 2 clinical trial by the end of January 2022, following the completion of further analyses. ¤½¥qÀÀ¦b2022¦~1¤ë©³«e¥l¶}¹q¸Ü·|ij¡A°Q½×³o¶µ¥þ²y2´ÁÁ{§É¸ÕÅ窺¸Ô²Ó¸ÕÅçµ²ªG¡A CBP-201 ²z½×¤W,´N¬O¥t¤@ÓDupilumab Àø®Ä¤£·|¤Ó®t,¦ýN=56:56 , ©â¼ËY¹³ASLAN004 1b ÂX¥R²Õ 27%«D IL4/IL13¾÷Âà, ¤Î13% ¤¤Â_²v. ¨ºÀø®Ä¼Æ¾Ú¤£¤Ó·Q¤½§G,è¦n¦Ó¤w. Lebrikizumab ¤T´Á,¥u¤½§G¤@ӼƾÚ,¹êÅç²ÕEASI75 >50% ,¨ä¥L没¤½§G. |
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·|û¡Gkim10134548 µoªí®É¶¡:2021/11/19 ¤W¤È 10:19:49²Ä 4901 ½g¦^À³
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¤Ñ©R¤j¡A½Ð°Ý¡G ¡u©Ò¦³CBP-201ªº¤TÓ²Õ¡A±q°ò½u¶}©l¡A¦b²Ä16 ¶g«áªºEASI µû¤À¡A»P¦w¼¢¾¯¬Û¤ñ¡A¹ê²{EASI-50 ©Î EASI-75Åã¥Ü¥X²Îp¾ÇÅãµÛ§ïµ½¡C¡v ¤W±³o¤@¬q¸Ü¡A¨S¦³´£¨ì¹ê²{EASI-90 ²Îp¾ÇÅãµÛ§ïµ½¡C¦pªG³o¥NªíEASI-90 ¨S¦³¹F¨ì²Îp¾ÇÅãµÛ§ïµ½¡A¨º»ò¬O§_´N¥i¥H±À½×¡ACBP-201 EASI-50 ©Î EASI-75ÁöµM¹F¨ì²Îp¾ÇÅãµÛ§ïµ½¡A¦ý¬O¥¼¨Ó¤½¥¬ªº¼Æ¾Ú¡A®£©È¤]¤£·|¦h»òº}«G¡A¹ï©óAD«¯g±wªÌ¡A¤]¤£·|¨º»ò¦³Àø®Ä©O¡H |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/19 ¤W¤È 09:34:30²Ä 4900 ½g¦^À³
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Dupilumab ªºÁ{§É¤¤¡A结½¤ª¢ªº¤ñ²v¤£¶W¹L6%, ¦ý²{¹êªº¬ã¨s¶W¹L40%. CBP-201 §@¥Î¦ì¸m¦PDupilumab, µ²½¤ª¢¶]¤£±¼¡C ²Ä¤G¶g´N¤£´±¥Î600mg. |
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·|û¡G¸Ø±i10133098 µoªí®É¶¡:2021/11/19 ¤W¤È 09:33:27²Ä 4899 ½g¦^À³
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³Ì«á¡A±µ¨ü CBP-201 ªº±wªÌ³ø§iªºª`®g³¡¦ì¤ÏÀ³ (1.8%) ©Mµ²½¤ª¢ (3.5%) µo¥Í²v¸û§C¡C µ²½¤ª¢ (3.5%) ¼Æ¾Ú³Q׺}«G¤F~~~«¢«¢«¢(³o»ò¥©§ùÁת¢°Æ§@¥Î¤]¬Oµ²½¤ª¢) |
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·|û¡G¸Ø±i10133098 µoªí®É¶¡:2021/11/19 ¤W¤È 09:15:00²Ä 4898 ½g¦^À³
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Connect Biopharma Holdings Limited ¨S»¡©ú CBP-201°Æ§@¥Î¬O§_¦³µ²½¤ª¢??? |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/19 ¤W¤È 08:58:46²Ä 4897 ½g¦^À³
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1.Lebrikizumab 2bAD Á{§É, 2018¦~2¤ë¶}©l,2020¦~1¤ë«Å¥¬³QLily¨ÖÁÊ.-----2¦~. 2.Dupilumab 2b AD Á{§É, 2013¦~5¤ë¶}©l,2017¦~3¤ë,¨ú±oÃĵý.-----------3¦~10Ó¤ë. ASLN004 2b AD Á{§É, ¹wp2021¦~11/12 ¤ë, (13Ӥ맹¦¨2b)¶}©l.-------«nùµ{¦ôp©M¤Wz2ÃĬۥh¤£»·. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/19 ¤W¤È 08:31:45²Ä 4896 ½g¦^À³
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Connect Biopharma Holdings Limited 2021 ¦~ 11 ¤ë 19 ¤é¡A¬P´Á¤¡A¤W¤È 5:02¡P8 ¤ÀÄÁ¾\Ū finance.yahoo.com/news/connect-biopharma-reports-positive-top-210200376.html ¥Dn²×ÂI¹F¨ì©Ò¦³¤TÓ CBP-201 ²Õ§¡¨ú±oÅãµÛ§ïµ½ ÁÙ³ø§i¤FÃöÁ䦸n²×ÂIªºÅãµÛ§ïµ½¡A¥]¬A¨Ï¥Î CBP-201 300 ²@§J¨C¨â¶g (Q2W) Áuªº¨ä¥L¥Ö½§²M°£©Mæ±Äo´ú¶q ¤½¥qÀÀ©ó2022¦~¤¤´Á±Ò°Ê²Ä¤T¶¥¬q¸ÕÅçp¹º ¤¤°êĬ¦{Éo¡¤à©M¤ÓÜ¡A2021 ¦~ 11 ¤ë 18 ¤é¡]Àô²y·s»DªÀ¡^--Connect Biopharma Holdings Limited¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GCNTB¡^¡]¡§Connect Biopharma¡¨©Î¡§¤½¥q¡¨¡^¡A¤@®a¥þ²yÁ{§É¶¥¬qªº¥Íª«»sÃĤ½¥q¡AP¤O©ó³q¹L¶}µo·½¦Û T ²ÓMÅX°Ê¬ã¨sªºÀøªk¨Ó§ïµ½ºC©Êª¢¯g¯e¯f±wªÌªº¥Í¬¡¡A¤µ¤Ñ³ø§i¤F CBP-201 ¥Ö¤U (SC) ¹ï¦¨¦~¤¤«×¦Ü¦¨¦~±wªÌªº¥þ²y 2 ´ÁÁ{§É¸ÕÅ窺¿n·¥³»½uµ²ªG- ÄY«ªº¯SÀ³©Ê¥Öª¢ (AD) (NCT04444752)¡C ¼Æ¾ÚÅã¥Ü¡A¸Ó¸ÕÅç¹F¨ì¤F¨ä¥DnÀø®Ä²×ÂI¡AÀã¯l±¿n©MÄY«µ{«×«ü¼Æ (EASI) µû¤À±q°ò½u¨ì²Ä 16 ¶gªº°§C¦Ê¤À¤ñ¦b²Îp¾Ç¤WÅãµÛ§ïµ½¡C©Ò¦³¤TÓ CBP-201 ²Õ ¡]300 ²@§J Q2W¡B150 ²@§J Q2W ©Î¦b²Ä 16 ¶g®É¡A¨C 4 ¶g 300 ²@§J¡]Q4W¡^¡^¦b²Îp¾Ç¤WÀu©ó¦w¼¢¾¯¡C¹ï©ó EASI ¦¸n²×ÂI¡A©Ò¦³¤TÓ CBP-201 ²Õ¦b¹ê²{ EASI µû¤À°§C¦Ü¤Ö 50% ©Î 75% ªº±wªÌ¤ñ¨Ò¤è±§¡Åã¥Ü¥X²Îp¾ÇÅãµÛ§ïµ½±q²Ä 16 ¶gªº°ò½u¶}©l¡A»P¦w¼¢¾¯¡]¤À§O¬° EASI-50 ©Î EASI-75¡^¬Û¤ñ¡C CBP-201 300mg Q2W »P¦w¼¢¾¯¬Û¤ñ¦b¨ä¥LÃöÁ䦸nÀø®Ä²×ÂI¤è±¤]¦³²Îp¾Ç·N¸qªºÅãµÛ§ïµ½¡A¥]¬A¹F¨ì 0 ©Î 1¡]²M´·©Î´X¥G²M´·¡^ªº½Õ¬dû¥þ²yµû¦ô¡]IGA¡^µû¤Àªº±wªÌ¤ñ¨Ò¥H¤Î≥²Ä 16 ¶g®É¤ñ°ò½u°ª 2 ¤À¡F¨C©P¥§¡®pÈæ±Äo¼Æȵû©w¶qªí (PP-NRS) ¥H¤Î¤@¨t¦C¨ä¥L²×ÂI±q°ò½u¨ì²Ä 16 ¶gªºÅܤơC ÁÙÆ[¹î¨ì CBP-201 ¨ã¦³¨}¦nªº¦w¥þ©Ê¡ACBP-201 ªvÀø²Õ©M¦w¼¢¾¯²Õ³ø§iªºªvÀøºò«æ¤£¨}¨Æ¥ó (TEAE)¡BÄY«¤£¨}¨Æ¥ó (SAE) ©M¾ÉP¬ã¨sÃĪ«°±ÃĪº TEAE µo¥Í²v¬Û¦ü¡C³Ì«á¡A±µ¨ü CBP-201 ªº±wªÌ³ø§iªºª`®g³¡¦ì¤ÏÀ³ (1.8%) ©Mµ²½¤ª¢ (3.5%) µo¥Í²v¸û§C¡C ¡§¾¨ºÞ±Á{ COVID-19 ¤j¬y¦æªº¬D¾Ô¡A§Ṳ́´«Ü°ª¿³¯à¦p´Á¦¨¥\§¹¦¨³o¶µ¸ÕÅç¡C¿n·¥ªºÀø®Ä©M¦w¥þ©Ê¼Æ¾Ú´£¨Ñ¤FÃB¥~ªºÃÒ¾Ú¡Aªí©ú CBP-201 ¦³¥i¯à¦¨¬°ªvÀø AD ªº«n¸É¥R¡A§Ú̪¾¹D³oºØ¯e¯f¨ã¦³²§½è©Ê¡A±wªÌ¤§¶¡ªºÅé¼x©M¯gª¬®t²§«Ü¤j¡A¡¨¾G°¶»¡¡A³Õ¤h¡AConnect Biopharma ªºÁp¦X³Ð©l¤Hݺ®u°õ¦æ©x¡C ¡§°ò©ó³o¨Çµ²ªG¡A§ÚÌ¥´ºâ¦b 2022 ¦~¤¤´Á±Ò°Ê²Ä 3 ¶¥¬q¸ÕÅçp¹º¡A¥H¶i¤@¨Bµû¦ô CBP-201¦b¸Ñ¨M¥¼º¡¨¬ªºªvÀø»Ý¨D¤è±¥i¯àµo´§ªº§@¥Î¡A³o¬OÀu¤Æ³\¦h AD ±wªÌµ²ªGªº»Ùê¡C³o¶µ¥þ²y 2 ´Á¸ÕÅç¤]¬O¤@Ó«nªº¨½µ{¸O¡A¥¦Åý§Ṳ́F¸Ñ CBP-201 ¦b¥Ø«e¥¿¦b¬ã¨sªº¨ä¥L¾AÀ³¯g¤¤ªº¼ç¤O¡A¥]¬A¤¤«×¦Ü««×«ùÄò©Êý³Ý©M¦ñ¦³»ó®§¦×ªººC©Ê»óÄuª¢¡C¡¨ CBP-201 ¥þ²y 2 ´ÁÁ{§É¸ÕÅç³]p ¥þ²y 2 ´ÁÁ{§É¸ÕÅ硧¤@¶µÃö©ó CBP-201 ¦b¤¤««×¯SÀ³©Ê¥Öª¢¦¨¤H¨ü¸ÕªÌ¤¤ªºÀø®Ä¡B¦w¥þ©Ê¡BÃÄ¥N°Ê¤O¾Ç©MÃĮľǪºÀH¾÷¡BÂùª¼¡B¦w¼¢¾¯¹ï·Óªº¦h¤¤¤ß¬ã¨s¡¨©Û¶Ò¤F 226 ¦W±wªÌ¡] 18-75 ·³¡^¹M¤Î¬ü°ê¡B¤¤°ê¡B¿D¤j§Q¨È©M·s¦èÄõ¡C±wªÌ³QÀH¾÷¤À°t¨ì¤TÓ CBP-201 ªvÀø²Õ¤§¤@©Î¦w¼¢¾¯²Õ¡C CBP-201 ªvÀø²Õ¦b²Ä 1 ¤Ñ³£±µ¨ü¤F 600 ²@§Jªºt²ü¾¯¶q¡AµM«á±µ¨ü¤F 300 ²@§J Q2W¡B150 ²@§J Q2W ©Î 300 ²@§J Q4W¡CªvÀø´Á¬° 16 ¶g¡A©Ò¦³±wªÌ§¡ÃB¥~ÀH³X 8 ¶g¡C CBP-201 ©M¦w¼¢¾¯³q¹L¥Ö¤U (SC) ª`®gµ¹ÃÄ¡C ¥DnÀø®Ä²×ÂI¬O»P¦w¼¢¾¯²Õ¬Û¤ñ¡A¨CÓ CBP-201 ²Õªº EASI µû¤À±q°ò½u¨ì²Ä 16 ¶gªº°§C¦Ê¤À¤ñ¡FÃöÁ䪺¦¸n²×ÂI¬O¬ã¨s¤Hû¥þ²yµû¦ô (IGA) µû¤À¬° 0 ©Î 1 ¥B¦b²Ä 16 ¶g®É°§C > 2 ¤Àªº±wªÌ¤ñ¨Ò¡F¦b²Ä 16 ¶g®É±q°ò½u¹F¨ì EASI-50¡BEASI-75 ©Î EASI-90 ªº±wªÌ¤ñ¨Ò¡F¥H¤Î¨C©P¥§¡ PP-NRS ±q°ò½u¨ì²Ä 16 ¶gªºÅܤơC¦w¥þ©Êµû¦ô¥]¬A³ø§iªº¤£¨}¨Æ¥ó (AE)¡B¥Í©RÅé¼x (VS)¡BÅéÀË©Mª`®g³¡¦ìÅܤơF¹êÅç«Ç©M¤ß¹q¹Ï (ECG) µû¦ô¡F¥H¤ÎÅã¥Ü§ÜÃĪ«§ÜÅé (ADA) ªº±wªÌ¼Æ¶q¡C ¤½¥qÀÀ¦b2022¦~1¤ë©³«e¥l¶}¹q¸Ü·|ij¡A°Q½×³o¶µ¥þ²y2´ÁÁ{§É¸ÕÅ窺¸Ô²Ó¸ÕÅçµ²ªG¡A SAN DIEGO and TAICANG, SUZHOU, China , Nov. 18, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the ¡§Company¡¨), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today reported positive topline results from the global Phase 2 clinical trial of CBP-201 administered subcutaneously (SC) to adult patients with moderate-to-severe atopic dermatitis (AD) (NCT04444752). The data show that the trial met its primary efficacy endpoint, with statistically significant improvements in the percentage reduction in the Eczema Area and Severity Index (EASI) score from baseline to Week 16. All three CBP-201 arms (300mg Q2W, 150mg Q2W or 300mg every four weeks (Q4W)) were statistically superior to placebo at Week 16. For EASI secondary endpoints, all three CBP-201 arms showed statistically significant improvements in the proportion of patients achieving at least a 50% or 75% reduction in EASI score from baseline at Week 16, compared with placebo (EASI-50 or EASI-75, respectively). Statistically significant improvements with CBP-201 300mg Q2W over placebo were also seen for other key secondary efficacy endpoints, including the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) and a reduction of ≥2 points from baseline at Week 16; and change from baseline to Week 16 in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS), as well as a range of other endpoints. CBP-201 was also observed to have a favorable safety profile, with a similar incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs leading to study drug discontinuation reported for CBP-201 treatment and placebo groups. Finally, there were a low reported incidence of injection site reactions (1.8%) and conjunctivitis (3.5%) in patients receiving CBP-201. ¡§We are very pleased to have successfully completed this trial on schedule despite the challenges of the COVID-19 pandemic. The positive efficacy and safety data provide additional evidence that CBP-201 has the potential to be an important addition to the armamentarium for the treatment of AD, a disease which we know is heterogenous with signs and symptoms varying greatly between patients,¡¨ said Zheng Wei, PhD, Co-Founder and CEO of Connect Biopharma. ¡§Based on these results, we intend to initiate a Phase 3 trial program in mid-2022 to further evaluate the role that CBP-201 may play in addressing the unmet therapeutic need that is a barrier to optimizing outcomes for many patients living with AD. This global Phase 2 trial is also an important milestone in informing us of the potential of CBP-201 in other indications currently being studied, including moderate-to-severe persistent asthma and chronic rhinosinusitis with nasal polyps.¡¨ CBP-201 Global Phase 2 Clinical Trial Design The global Phase 2 clinical trial, ¡§A Randomized, Double-Blind, Placebo-Controlled Multi-Centered Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of CBP-201 in Adult Subjects with Moderate to Severe Atopic Dermatitis,¡¨ enrolled 226 patients (ages 18¡V75 years) throughout the United States, China, Australia and New Zealand. Patients were randomized to one of three CBP-201 treatment groups or the placebo group. The CBP-201 treatment groups all received a 600 mg loading dose on Day 1 and then received 300 mg Q2W, 150 mg Q2W or 300 mg Q4W. The treatment period was 16 weeks, and all patients were followed for an additional period of 8 weeks. CBP-201 and placebo were administered via subcutaneous (SC) injection. The primary efficacy endpoint was percentage reduction in the EASI score from baseline to Week 16 for each CBP-201 group compared with the placebo group; the key secondary endpoints were the proportion of patients with an Investigator Global Assessment (IGA) score 0 or 1 and a reduction of >2 points at Week 16; the proportion of patients achieving EASI-50, EASI-75 or EASI-90 from baseline at Week 16; and change from baseline to Week 16 in weekly average PP-NRS. Safety assessments included reported adverse events (AEs), vital signs (VS), physical examinations and injection site changes; laboratory and electrocardiogram (ECG) evaluations; and the number of patients displaying anti-drug antibodies (ADA). The Company intends to hold a conference call to discuss the detailed trial results from this global Phase 2 clinical trial by the end of January 2022, following the completion of further analyses. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/19 ¤W¤È 08:12:41²Ä 4895 ½g¦^À³
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Connect Biopharma Reports Positive Top-Line Results from the Global Phase 2 Clinical Trial of CBP-201 in Patients with Moderate-to-Severe Atopic Dermatitis Connect Biopharma Holdings Limited Fri, November 19, 2021, 5:02 AM¡P8 min read finance.yahoo.com/news/connect-biopharma-reports-positive-top-210200376.html CNTB ¤½§i CBP-201 ¤G´Á ¤¤-««×AD ¦UÁ{§É«ü¼Ð©M¹ï·Ó组¤§¶¡¬Ò¦³统p¤Wªº©úÅã®t²§¡C ¹êÅç组¤À150mg/300mg----¨C¨â¶g¤@°w¡A300mg¡K¡K¨C¥|¶g¤@°w¡C ¤µ¤ÑµL¥ô¦ó¼Æ¦r¤½§G¡C 2022¦~¤¸¤ë©³¡A·|Á|¿ì¼Æ¾Úµoªí·|¡C 2022¦~¤¤¡A¶}©l¤T´ÁÁ{§É¡C ¥Ø«e½L«á¤j¶^25%¡A¶^¦Ü9¬ü¤¸¡C 8¤ë³Ì°ª29¬ü¤¸/ªÑ,¤w¤j¶^70%. ¦~©³«e·ÀI¡G¤¤°ê©Ò¦³¦b¬ü¤W¥«ªÑ²¼¡A¥i¯à³Q¬ü°ê¬F©²¤U¥«¡C ¦]¬°¤¤°ê¬F©²¤£¦P·N¬ü°êªº·|p®v¬d¤¤°ê¤½¥qªº±b¡C |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/11/18 ¤W¤È 08:58:39²Ä 4894 ½g¦^À³
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www.globenewswire.com/en/news-release/2020/10/16/2109729/0/en/ASLAN-Pharmaceuticals-to-Develop-ASLAN003-as-Next-Generation-DHODH-Inhibitor-in-Autoimmune-Conditions.html - ¾ÌÂÇ °w¹ï SARS-CoV-2 ªº¯Ç¼¯º¸®Ä¤O¡AASLAN 003 ¤]¥¿¦bµû¦ô¨ä§@¬°COVID-19©M¨ä¥L¯f¬rªº·s«¬ªvÀø¾¯ªº¼ç¤O 003°£¤F¹ïIBDªº¬ã¨s¡AªGµM¤]¦³°w¹ï covid19ªº¬ã¨s ¦¨®Ä¦p¦óÀ³¸Ó©ú¦~²Ä¤@©u¹ï003 ªº³ø§i´N¥i¬Ý¥XºÝÙ |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/18 ¤W¤È 08:41:56²Ä 4893 ½g¦^À³
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¥H¤W13®a¾÷ºcÁ`«ùªÑ22,438¤dªÑ,¦û¥Ø«eASLN ADR ,¤wµo¦æ¬ù 70,000¤dªÑ¸ê¥»ÃBªº32%. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/18 ¤W¤È 08:27:34²Ä 4892 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/17 ¤U¤È 02:58:58²Ä 4890 ½g¦^À³
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ASLN ¾÷ºc Q3 ,«ùªÑÅܤÆ: whalewisdom.com/stock/asln ¬°¥Dn¤T¤j½æ¶W¨Ó·½ 1.LOGOS GLOBAL MANAGEMENT LP ½æ¶W2,000¤dªÑ 2.ASYMMETRY CAPITAL MANAGEMENT, L.P. ½æ¶W1,194¤dªÑ 3.ORBIMED ADVISORS LLC ½æ¶W550¤dªÑ ------------------------------------------------------- ¤pp ½æ¶W3744¤dªÑ, ¦û©Ò¦³½æ¶W5150¤dªÑ72%. ¬°¥Dn¤T¤j¶R¶W¨Ó·½ 1.TANG CAPITAL MANAGEMENT LLC 975 ¤dªÑ 2.AFFINITY ASSET ADVISORS, LLC 250,¤dªÑ 3.POINT72 ASSET MANAGEMENT, L.P. 250,¤dªÑ ¤pp ¶R¶W1475¤dªÑ, ¦û©Ò¦³¶R¶W2900¤dªÑ51%. ¤@.ASLN 2021/Q3, ½æ¶W ¾÷ºc, ¦Xp ¬ù5,150¤dªÑ LOGOS GLOBAL MANAGEMENT LP 0.55 62 2,000,000 0.0000% 13F 2021-09-30 2021-11-15 Q1 2021 ASYMMETRY CAPITAL MANAGEMENT, L.P. 2.71 Sold All 1,194,070 0.0000% 13F 2021-09-30 2021-11-04 Q1 2021 ORBIMED ADVISORS LLC 1,970,000 $3,507,000 0.04 0.08 162 550,000 5.1854% 13F 2021-09-30 2021-11-15 Q1 2021 GOLDMAN SACHS GROUP INC 29,235 $52,000 0.00 0.00 6040 383,022 0.0770% 13F 2021-09-30 2021-11-10 Q1 2021 RENAISSANCE TECHNOLOGIES LLC 118,558 $211,000 0.00 0.00 3186 241,091 0.3121% 13F 2021-09-30 2021-11-12 Q4 2019 PARKMAN HEALTHCARE PARTNERS LLC 0.16 Sold All 225,881 0.0000% 13F 2021-09-30 2021-11-12 Q1 2021 SIO CAPITAL MANAGEMENT, LLC 1,270,758 $2,262,000 0.72 1.22 39 217,750 3.3449% 13F 2021-09-30 2021-11-15 Q4 2019 CITADEL ADVISORS LLC 2,749,019 $4,893,000 0.00 0.00 4334 149,279 7.2360% 13F 2021-09-30 2021-11-15 Q4 2020 SABBY MANAGEMENT, LLC 688,400 $1,225,000 0.17 0.36 80 76,876 1.8120% 13F 2021-09-30 2021-11-15 Q1 2021 ATOM INVESTORS LP 0.03 Sold All 61,507 0.0000% 13F 2021-09-30 2021-11-15 Q1 2021 SCHONFELD STRATEGIC ADVISORS LLC 0.00 Sold All 45,500 0.0000% 13F 2021-09-30 2021-11-16 Q1 2021 JUMP FINANCIAL, LLC 0.01 Sold All 37,400 0.0000% 13F 2021-09-30 2021-11-12 Q2 2021 TWO SIGMA ADVISERS, LP 19,000 $34,000 0.00 0.00 2392 14,500 ¤G.ASLN 2021/Q3, ¶R¶W ¾÷ºc, ¦Xp ¬ù2,900¤dªÑ TANG CAPITAL MANAGEMENT LLC 975,305 $1,736,000 0.36 20 975,305 2.5672% 13F 2021-09-30 2021-11-15 Q3 2021 AFFINITY ASSET ADVISORS, LLC 250,000 $445,000 0.11 69 250,000 0.6581% 13F 2021-09-30 2021-11-12 Q1 2021 POINT72 ASSET MANAGEMENT, L.P. 250,000 $445,000 0.00 931 250,000 0.6581% 13F 2021-09-30 2021-11-15 Q3 2021 SUSQUEHANNA INTERNATIONAL GROUP, LLP 224,425 $399,000 0.00 9939 224,425 0.5907% 13F 2021-09-30 2021-11-15 Q3 2021 SUSQUEHANNA INTERNATIONAL GROUP, LLP(PUT) 224,400 $399,000 0.00 9938 224,400 13F 2021-09-30 2021-11-15 Q3 2021 IKARIAN CAPITAL, LLC 1,417,348 $288,000 0.02 0.02 197 192,832 3.7307% 13F 2021-09-30 2021-11-15 Q4 2020 MILLENNIUM MANAGEMENT LLC 1,468,207 $2,613,000 0.00 0.00 3599 118,919 3.8646% 13F 2021-09-30 2021-11-15 Q1 2021 LMR PARTNERS LLP 92,163 $164,000 0.00 940 92,163 0.2426% 13F 2021-09-30 2021-11-15 Q3 2021 CITADEL ADVISORS LLC(PUT) 74,000 $132,000 0.00 12504 74,000 13F 2021-09-30 2021-11-15 Q3 2021 STATE STREET CORP 96,629 $172,000 0.00 4401 64,250 0.2543% 13F 2021-09-30 2021-11-15 Q4 2020 BARCLAYS PLC 188,764 $336,000 0.00 0.00 3373 60,488 0.4969% 13F 2021-09-30 2021-11-09 Q1 2021 BOOTHBAY FUND MANAGEMENT, LLC 187,862 $334,000 0.01 0.01 1274 56,943 0.4945% 13F 2021-09-30 2021-11-15 Q4 2020 DAFNA CAPITAL MANAGEMENT LLC 732,500 $1,304,000 0.35 0.47 63 55,000 1.9281% 13F 2021-09-30 2021-11-15 Q4 2019 VIRTU FINANCIAL LLC 52,590 $94,000 0.01 1163 52,590 0.1384% 13F 2021-09-30 2021-11-12 Q4 2020 GEODE CAPITAL MANAGEMENT, LLC 181,659 $323,000 0.00 4236 46,639 0.4782% 13F 2021-09-30 2021-11-12 Q1 2021 MYDA ADVISORS LLC 236,165 $420,000 0.12 0.17 169 25,000 0.6216% 13F 2021-09-30 2021-11-12 Q1 2021 GROUP ONE TRADING, L.P.(CALL) 17,400 $31,000 6887 17,400 13F 2021-09-30 2021-11-12 Q3 2021 GROUP ONE TRADING, L.P. 16,676 $30,000 6901 16,676 0.0439% 13F 2021-09-30 2021-11-12 Q3 2021 CUTLER GROUP LP(PUT) 15,500 $11,000 0.00 3881 15,500 13F 2021-09-30 2021-10-26 Q3 2021 HRT FINANCIAL LP 15,060 $26,000 0.00 3131 15,060 0.0396% 13F 2021-09-30 2021-11-15 Q3 2021 MORGAN STANLEY 239,508 $426,000 0.00 0.00 5578 8,049 0.6304% 13F 2021-09-30 2021-11-15 Q4 2019 UBS GROUP AG 11,793 $21,000 7092 7,529 0.0310% 13F 2021-09-30 2021-11-15 Q4 2018 CUTLER GROUP LP(CALL) 6,900 5652 6,900 13F 2021-09-30 2021-10-26 Q3 2021 CUTLER GROUP LP 4,000 $7,000 0.00 4243 4,000 0.0105% 13F 2021-09-30 2021-10-26 Q3 2021 CUBIST SYSTEMATIC STRATEGIES, LLC 3,727 $7,000 0.00 2913 3,727 0.0098% 13F 2021-09-30 2021-11-15 Q3 2021 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/15 ¤W¤È 08:56:29²Ä 4889 ½g¦^À³
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没¦³¬ã¨s,¦p¦óªø§ëREGN ? ªk°êÁɸãµá,2005¦~ªø§ë«ùªÑ20%. 2011¦~11¤ëEylea¤W¥«(²Ä¤@ÓÃĤW¥«) finance.yahoo.com/quote/REGN --------------------------------------- ¥þ²y¾P°âª÷ÃB¡]»õ¬üª÷) PK ¡X- A:Lucentis) //B:(Eylea)**B/A**¦XpA+B 2006(¤W¥«//) 2009¡V20.35// ¡]Eylea ,2001¦~11¤ë FDA ®Öã¤W¥«) 2012¡V24.00//8.70**B/A=36%**32.7 --------(Eylea²Ä¤@¦~¾P°â, ¦~«×¶O¥Î16,000¬ü¤¸¨C2Ӥ르¤@°w vs Lu centis 24000¬ü¤¸/¨C¤ë¤@°w) 2013¡V39.53//20.43**B/A=51%**50.96 ¡]2013/10¤ë¡A¤ÀªR®v¦ô2018/Eylea 47»õ¬ü¤¸) 2014¡V43.00//28.00**B/A=65%**71 2015¡V34.00//40.8.00**B/A=120%**74.8 (Lucentis ¡¥s ¥é¥ÍÃĦL«×¤W¥«//Eylea ¤W¥«²Ä¥|¦~,¦~¾P°â¶W¹LLucentis)) 2016¡V33.00//55.38**B/A=161%**88.38 2017¡V33.00//62.82**B/A=190%**95.82 2018¡V37.00//67.00**B/A=181%**104 2019¡V41(¦ô)//78.52**B/A=191%**119 ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X- AMD¡X¡X°w¾¯ Ävª§¥v¡]ªvÀø¡X²´·ú¶À¯Z³¡¯fÅÜ¡^ ¤@¡BLucentis¡]Ranibizumab¡^¡X¡X2006¦~6¤ë¡AFDA®Öã¤W¥«,ù¤ó(¬ü°ê¾P°â)/¿ÕµØ(¨ä¥L¦a°Ï¾P°â) ¡A¨C¤ë¤@°w¡A¨C¦~24,000¬ü¤¸Àøµ{¶O¥Î ¤G¡BEylea¡]aflibercept¡^¡X¡X-2011¦~11¤ë,FDA®Öã¤W¥«¡ARegeneron Pharmaceuticals(¬ü°ê¾P°â)/«ô¦Õ(¨ä¥L¦a°Ï¾P°â,§Q¼í§¡¤À)¡A¨C2¤ë¤@°w¡A¨C¦~16,000¬ü¤¸Àøµ{¶O¥Î¡C Lucentis¡]Ranibizumab¡^ ©MEylea¡]aflibercept¡^ ¬O¥Ø«e¼sªx¥Î©ó²´¬ì¯e¯fªºÀøªk¡AªvÀø¥]¬A·s¥Í¦åºÞ¡]Àã©Ê¡^¦~ÄÖ¬ÛÃö©Ê¶À´³ÅÜ©Ê¡Bµøºô½¤ÀR¯ßªý¶ë«á¶À´³¤ô¸~¡B¿}§¿¯f©Ê¶À´³¤ô¸~¡]DME¡^©MDME¦ñ¦³¿}§¿¯f©Êµøºô½¤¯fÅÜ¡C ¨âªÌ§¡¬°§Ü¦åºÞ¤º¥Ö¥Íªø¦]¤l¡]VEGF¡^Àøªk¡C2018¦~¡A³o¨â´ÚÃĪ«ªº¥þ²y¾P°âÃB±µªñ110»õ¬ü¤¸¡A¶È¦b¬ü°êªº¾P°âÃB´N¶W¹L¤F58»õ¬ü¤¸¡C Lucentis¦b¬ü°êªº±M§Q±N©ó2020¦~¨ì´Á¡A¦ý¹w´ú2021¦~¾P°âÃB¤´±N¹F¨ì41»õ¬ü¤¸¡C 2015¦~²Ä¤@Ó¥é¥ÍÃÄ¡A¦L«×¤W¥« 75%»ù®æ¡C Eyleaªº¤@¶µÃöÁä±M§Q¦b¬ü°ê±N©ó2023¦~¨ì´Á¡A¦b¼Ú¬w¨ì2025¦~¤~¨ì´Á¡A¹wp2021¦~¾P°âÃB±N¹F¨ì70»õ¬ü¤¸¡C |
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·|û¡G¤p¾ð10027223 µoªí®É¶¡:2021/11/15 ¤W¤È 08:46:21²Ä 4888 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/14 ¤W¤È 10:31:22²Ä 4887 ½g¦^À³
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.¥¼¨Ó¨ÖÁʵo¥Í,¥i¯à¦X¬ù: (a)11/(b)50*(c)120*(d)2=52.8»õ¬ü¤¸(¨È·à¿W±o) (a)Lebrikizumab AD³Q¨Ö»ù11»õ¬ü¤¸/(b)2019¦~dupilumab 50»õ¬ü¤¸³Ì°ª¾P°â¹w´ú*(c)2021¦~dupilumab 120»õ¬ü¤¸³Ì°ª¾P°â¹w´ú *(d)2 ¿(¨ä¥L004¾AÀ³¯gý³Ý/COPD/EOE...¤ÎASLAN003»ùÈ.) ¡X¡X¦ô2022¦~¤U¥b¦~«áÀH®É¯àµo¥Í --¨ÖÁʪ̥t¶·¤ä¥ICSL¤W´å¦X¬ù. 52.8»õ¬ü¤¸/70,000,000ªÑ(ADR ¥Ø«eªÑ¥»70,000,000ªÑ)=75 ¬ü¤¸/ªÑ---(2023¦~Q1«e³Q¨ÖÁÊ) -------------------------------------------------------------------------------- ¥¼¨Ó¦AÄw¸ê°µ¤T´Á, ¦ô (1)µo¦æ·sªÑ30,000,000ªÑ*6.4¬ü¤¸=1.92»õ¬ü¤¸ (2)«D¬ü°ÏAD±ÂÅv 1.98*120/50=4.75»õ¬ü¤¸(«eª÷+¨úµýùµ{ª÷) 52.8»õ¬ü¤¸/100,000,000ªÑ(ADR ¥¼¨ÓªÑ¥»(2023/Q2)100,000,000ªÑ)=52.8 ¬ü¤¸/ªÑ(2023¦~Q2«á³Q¨Ö) |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/11/14 ¤W¤È 09:49:29²Ä 4886 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/13 ¤W¤È 11:22:28²Ä 4885 ½g¦^À³
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2029¦~ªvÀø¤¤-««×AD ,¥Íª«»s¾¯, ¦ô¾P240»õ¬ü¤¸ VS 2021¦~63»õ. 2030¦~ªvÀø¤¤-««×ý³Ý ,¥Íª«»s¾¯, ¦ô¾P200»õ¬ü¤¸ VS 2021¦~60~70»õ.(¤w¦³5ºØ¤W¥« IL5*33+ IL4 +IgE) mops.twse.com.tw/nas/STR/474320211008M002.pdf |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/13 ¤W¤È 11:06:45²Ä 4884 ½g¦^À³
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3.ªvÀø¤¤-««×ADÀø®Ä¬ùDUPILUMAB 100%~130%, ASLAN004 ¦ô, 35~45»õ¬ü¤¸. ý³Ý¤Î¨ä¥L¾AÀ³¯g+ASLAN003 ¬ù¼W¤@¿, ¦Xp ¦ô³Ì°ª¾P°â70~90»õ¬ü¤¸. ----------------------------------------------------------------- 1.ªvÀø¤¤-««×ADÀø®Ä¶È¬ùDUPILUMAB 75%, Lebrikizumab¦ô,°ª®p¦~¾P°â25»õ¬ü¤¸. 2019/02 ,Dermira ¦A±Â¥X¼Ú¬wLebrikizumab °Ó·~¤ÆÅv¤Oµ¹Almirall,¤½¥q. Out-License and Other Agreements \Almirall Agreement ·í®ÉAlmirall CEO ¦ô¼Ú¬w³Ì°ª¾P°â5»õ¬ü¤¸, (¦û¥þ²y¬ù20%) 5/20%=25»õ¬ü¤¸,---¦ôp¥þ²y¾P°â°ª峄. 2.ªvÀø¤¤-««×ADÀø®Ä¶È¬ùDUPILUMAB 50%, Adtralza (tralokinumab)¦ô,2027 ¦~¾P°â16»õ¬ü¤¸. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/13 ¤W¤È 10:33:31²Ä 4883 ½g¦^À³
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ªvÀø¤¤-««×ADÀø®Ä¶È¬ùDUPILUMAB 50%, Adtralza (tralokinumab)¦ô,2027 ¦~¾P°â16»õ¬ü¤¸. --------------------------------- remapconsulting.com/blockbuster-drugs-of-the-next-decade/ ªü¯S©Ô¤ã¡]¯S©Ô¬¥°ò§V°¨¥¬¡^ Adtralza ©ó 2021 ¦~ 6 ¤ëÀò±o EMA §åã¡A¥Î©óªvÀø¦¨¤H±wªÌ¤¤«×¦Ü««×¯S²§©Ê¥Öª¢¡A³o¨Ç±wªÌ¬O¥þ¨ªvÀøªºÔ¿ïªÌ¡C¥¿¦b¦V¬ü°ê¹«~©MÃĪ«ºÞ²z§½¡]FDA¡^©M¥þ²y¨ä¥L½Ã¥Í·í§½´£¥æ§ó¦hºÊºÞÀÉ¡C¸ÓÃĪ«¤w¸g¶}µo¡A±N¥ÑLEO»sÃĤ½¥q¾P°â¡A³o¬O¥Ö½§¬ì»â°ì³Ì±j¤jªº°Ñ»PªÌ¤§¤@¡CAdtralzaªº§åã¬O°ò©óECZTRA 1¡A2©M3ÃöÁ䶥¬q3¸ÕÅ窺Àø®Ä©M¦w¥þµ²ªG¡A¨ä¤¤¥]¬A1¡A900¦h¦W¦¨¤H±wªÌ¤¤«×¦Ü««×¥Öª¢9¡C ¸ÓÃĪ«¦b16©PªºªvÀø¤¤ªí²{¥XÀu©ó¦w¼¢¾¯ªºÀu¶V©Ê¡A¦b¦hÓµ²ªG±¹¬I¤Ï¬M¯S²§©Ê¥Öª¢10ªº¸ñ¶H©MÄpª¬¡C¹wp¨ì2027¦~¡AAdtralzaªº¾P°âÃB±N¹F¨ì16»õ¬ü¤¸ 7. Adtralza (tralokinumab) Adtralza was approved in June 2021 by the EMA for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. Additional regulatory filings are underway with the US FDA and other health authorities worldwide. The drug has been developed and will be marketed by LEO Pharma, one of the strongest players in the field of dermatology. Adtralza¡¦s approval was based on efficacy and safety results from the ECZTRA 1,2 and 3 pivotal Phase 3 trials, which included more than 1,900 adult patients with moderate-to-severe dermatitis9. The drug demonstrated superiority over placebo during 16 weeks of treatment across multiple outcome measures reflecting the signs and symptoms of atopic dermatitis10. Adtralza is projected to generate $1.6 billion in sales by 2027. ----------------- What will be the blockbuster drugs in the next decade? Which treatments have been recently approved by the regulators in the US and EU? Until June 30th, 2021, the Food and Drug Administration (FDA) in the US and European Medicine Agency in Europe have launched 32 and 22 new drugs, respectively1. This represents a notable increase in the number of approved molecules by the two regulators during the first half of 20202. There are different speculations what the reason for that might be, but one of them is that regulators have adapted to operate amidst the Covid-19 pandemic. The table below shows the eight most promising recently approved treatments by the FDA or European Medicine Agency (EMA) measured by their sales forecast. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/13 ¤W¤È 10:15:03²Ä 4882 ½g¦^À³
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Adtralza® (tralokinumab) ¤µ¦~6¤ë¤v¨ú±o¼Ú¬w+^Ãĵý . LEO ªí¥Ü¬ü°êÃĵý¹wp©ú¦~ªì¨ú±o. www.businesswire.com/news/home/20210621005564/en/LEO-Pharma-announces-European-Commission-approval-of-Adtralza%C2%AE-tralokinumab-as-the-first-and-only-treatment-specifically-targeting-IL-13-for-adults-with-moderate-to-severe-atopic-dermatitis LEO Pharma announces European Commission approval of Adtralza® (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults with moderate-to-severe atopic dermatitis The European Commission regulatory approval is primarily supported by data from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, in which Adtralza demonstrated significant improvements in atopic dermatitis signs and symptoms, with treatment response rates gradually improved and maintained over time1-3 Adtralza was generally well tolerated with an overall frequency and severity of adverse events comparable with placebo1-3 Adtralza was also shown to reduce itch and improve health-related quality of life1-3 June 22, 2021 02:00 AM Eastern Daylight Time BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Commission (EC) has approved Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The European approval makes Adtralza the first high affinity, fully human monoclonal antibody approved to specifically bind to and inhibit the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.1,4,5 Adtralza will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week.1 Adtralza can be used with or without topical corticosteroids (TCS).1 ¡§This European Commission approval of Adtralza means that clinicians across Europe now have an important new treatment option for adult patients with moderate-to-severe atopic dermatitis, which is a chronic, unpredictable skin disease,¡¨ said Stephan Weidinger, MD, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Kiel, Germany and tralokinumab clinical trial investigator. ¡§By specifically targeting IL-13 with high affinity, Adtralza has demonstrated that it can reduce atopic dermatitis signs and symptoms and sustain improvements over time.¡¨ The approval is based primarily on efficacy and safety results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included more than 1,900 adult patients with moderate-to-severe atopic dermatitis.1 Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-ranging trial, and a vaccine response trial.1 ¡§This European Commission approval of Adtralza is an important development for the millions of adults in Europe who are living with this often uncontrolled skin disease,¡¨ said Catherine Mazzacco, President and CEO of LEO Pharma. ¡§We are proud to have the opportunity to offer a new long-term treatment option for moderate-to-severe atopic dermatitis and are working closely with key stakeholders to enable access to Adtralza for eligible patients.¡¨ The European Commission decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein. Additional regulatory filings are underway with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and other health authorities worldwide. About Adtralza (tralokinumab) Adtralza (tralokinumab) is a fully human, monoclonal antibody developed to specifically neutralize the IL-13 cytokine, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms. Adtralza specifically binds to the IL-13 cytokine with high affinity, thereby preventing interaction with the IL-13 receptor £\1 and £\2 subunits (IL-13R£\1 and IL-13R£\2).4,5 About the pivotal ECZTRA 1, 2, and ECZTRA 3 Trials ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the safety and efficacy of Adtralza (300 mg) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.2 ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the safety and efficacy of Adtralza (300 mg) in combination with TCS in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.3 About atopic dermatitis Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.6 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.7 Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.4 About LEO Pharma LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10,133 million. For more information please visit www.LEO-Pharma.com. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/13 ¤W¤È 07:22:19²Ä 4881 ½g¦^À³
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IVL-094¡AIL22§í¨î¾¯¡AªvÀø¤¤-««×AD¡A Àø®Ä谮¤O¥Ñ¨ä2aÁ{§É¬Ý¨Ó约Dupilumabªº33%%-50%. ¤¤«×SCORAD<50 ¡A¦û©Û¶Ò50%¡A©M¹ï·Ó组¡AÀø®Äp>0.05¡AµL²Îp¤WÅãµÛ®t²§¡C ì¦]¥i¯à¬OIL4/IL13ªºII«¬¾÷Âà¦û¤j³¡¥÷¡C ¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K ASLAN004 2b ,IL22 ¥Íª««ü¼Ð¡AYÅã¥Ü°ªIL22组¡AÀø®Ä©M¹ï·Ó组µL®t²§¡C IVL-094,ªº¼ç¦b»ùÈ´N¯B²{¡C ASLAN004+ILV-094ªvÀøADªºÂù¼Ð¹vÃĪ«´N¥i¯à·|¶i¤JÁ{§É¡C Àø®Ä¤ñASLAN004/Dupilumab³æÃÄ¡A¦ô¦A¼W¥[33%-50%¡C ¡«á IGA 0,1 Dupilumab 39% ¦ô ASLAN004 >39%+ILV-094 13%-19.5% =>52%-58.5% |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/12 ¤U¤È 08:53:20²Ä 4880 ½g¦^À³
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Emma Guttman-Yassky, MD, PhD--------¥ç¬OILV-094 IL22 AD ,2a (N=40+20)ªºº®u³ø§i¤H. ¦b´Á¥Z¤¤¦³¸Ô²Ó¤ÀÍQ °Q½×: ¦b¸ûÄY«ªºAD±Ú¸s¤¤,P<0.05, ¦ý¸û»´¯gAD©M¹ï·Ó²ÕµL®t²§. ------------------------------------------ °Q½× ³o¬O²Ä¤@Ó¦b AD ±wªÌ¤¤¬ã¨s IL-22 ªýÂ_ªºÁ{§É¸ÕÅç¡A¤]¬O²Ä¤@Óªí©ú IL-22 ¦b¥ô¦ó¤HÃþ¯e¯f¤¤¨ã¦³P¯f§@¥ÎªºÁ{§É¸ÕÅç¡C»P¦w¼¢¾¯¬Û¤ñ¡AFezakinumab ªvÀø¦¨¤H¤¤««× AD ¾ÉPÁ{§É©M¤À¤l¯e¯fµû¤À«ùÄò§ïµ½¡C ¦b²Ä 12 ¶g¡A»P¦w¼¢¾¯ªvÀøªº±wªÌ¬Û¤ñ¡AÃĪ«ªvÀøªºÅãµÛÁ{§É§ïµ½¦b««× AD ±wªÌ¡]°ò½u SCORAD ≥50¡^¤¤³Ì¬°©úÅã¡C ¦¹¥~¡Aª½¨ì²Ä 20 ¶g¡A§Y³Ì«á¤@¦¸µ¹ÃÄ«á 10 ¶g¡AÆ[¹î¨ì©Ò¦³µ²ªG«ü¼Ðªº³vº¥§ïµ½¡Aªí©úªvÀøµ²§ô«áÃĪ«¤ÏÀ³«ùÄò¡C ³o¶µ¬ã¨s¬O¤HÃþªº²Ä¤@ÓÃÒ¾Ú¡A»P TH2 ²ÓM¦]¤l IL-4 ©M IL-13, Ãþ¦ü¡AIL-22 ¬O AD ªºÃöÁäÅX°Ê¦]¯À¡C ¾¨ºÞ¥Ø«e¤w§åã©Î¥¿¦bÃĪ«¸ÕÅ礤´ú¸Õªº³æ§J¶©§ÜÅéªvÀø¤èªk°w¹ï AD ¤¤ªº TH2 ³q¸ô¡A ³o¨Ç¼Æ¾Ú¬° AD ©M¨ä¥L¯e¯fªº¥¼¨ÓªvÀøµ¦²¤´£¨Ñ¤F¥þ·sªº¾÷¨î¡A¨ä¤¤ IL-22 ¥i¯à¨ã¦³¤@Ó¨¤¦â¡A ¨Ò¦p¤p¨à»È®h¯f 14 ©Î¤p¨à AD. ¯S§O¬O¦bÄY« AD ±wªÌ²Õ¤¤¥i¥H¬Ý¨ì§ó¤j©M§óÅãµÛªº®t²§¡C ¤¤«× AD ¶¤¦C¤¤²ÎpÅãµÛ©Ê°§Cªº¥i¯àì¦]¥i¯à¬O¥Ñ©ó¸û§Cªº°ò½u¯e¯f¦Ó¾ÉP§ó°ªªºÅܲ§©Ê©M§ó§Cªº³Ì¤j®t²§¡C ««× AD ±wªÌªº¯e¯fÄY«µ{«×¸û°ª¡A¨Ã¥B³q±`ªí²{¥X¸û¤pªºªi°Ê¡A±q¦Ó¤¹³\ªvÀø¤ÏÀ³¦s¦b¸û¤j®t²§¡C Á{§Éµ²ªG´ú¶qªº±Ó·P©Ê³q±`ÀHµÛ°ò½u¯e¯f¬¡°Ê«×ªº¼W¥[¦Ó¼W¥[¡A¨Ã¥BÅã¥Ü¥X¸û§Cªº¥i«½Æ©Ê¸û§Cªº¤À¼Æ¡A ²{¦b¦b¸ÕÅç³]p¤¤¶V¨Ó¶V¦h¦a»{ÃѨì³o¤@¨Æ¹ê¡C §Ú̪º¬ã¨s¦³¤@¨Ç§½©Ê¡Cº¥ý¡A§Ú̪º¬ã¨s¬O¦b 6 ¦~«e³]pªº¡A¶È¨Ï¥Î SCORAD ¨Ó¿Å¶q¯e¯fÄY«µ{«×¡AÃþ¦ü©ó·í®É³]pªº³\¦h¬ã¨s¡A¦Ó·í«eªº AD ¸ÕÅç³q±`¨Ï¥ÎÀã¯l±¿n©MÄY«µ{«×«ü¼Æ (EASI) µû¤À§@¬°¥Dnµ²ªG¡A¨î¤F»P¨ä¥LÁ{§É¸ÕÅç¶i¦æ¤ñ¸ûªº¯à¤O¡C¾¨ºÞ¦p¦¹¡A³Ìªñªº¬ã¨s¦P®É¦Ò¼{¤F³o¨âºØ´ú¶q¤èªk¡A¦b³o¨Ç¬ã¨s¤¤¡ASCORAD ¦ü¥G¬O¤@ºØ§óÄY®æªº¯e¯f´ú¶q¤èªk¡F EASI ¤À¼ÆªºÅܤƩ¹©¹¤ñ¦U¦Ûªº SCORAD ÅܤƤj±o¦h¡C ¨ä¦¸¡A§Ú̪º¬ã¨s¬O¦b¥X²{ AD ¬O¤@ºØ²§½è©Ê¯e¯fªº¼Æ¾Ú¤§«e³]pªº¡A³o»Ýn¤@Ó¬ã¨s³]p¡A¤¹³\¹ï¤l¶°¶i¦æ¤ÀªR¤H¤f¡C¬°¤F¸Ñ¨M³oÓ°ÝÃD¡A§Ų́ϥΤF¤@ºØ¨Æ«á¤ÀªR¤èªk¡A±N««×©M¤¤«×¯e¯f±wªÌ¤À¶}¡C »Ýn§ó¤j³W¼Òªº¬ã¨s¨Ó»P¨ä¥LªvÀø¤èªk¶i¦æ¤ñ¸û¨Ã½T»{¦b AD ¨È²Õ¡]¨Ò¦p¡A¤¤«×»P««×¯e¯f¡B¤£¦PºØ±Ú¡^¤¤ªºÀø®Ä¡C ³o¶µ¬ã¨s±o¨ì¤F IL-22 «ú§Ü¾¯»P¦w¼¢¾¯ªºº¥¶i¦¡Á{§É§ïµ½ªº¤ä«ù¡A´¦¥Ü¤F¤@ºØ·sªº AD ªvÀø½d¦¡¡A¯S§O¬OÄY«ªº AD¡A¥Ñ©ó¨ä¨Ï¤Hµê®zªº©Ê½è©M¹ï±wªÌªº¯}Ãa©Ê¼vÅT¡A¸Ó¤H¸s¹ï§ó¦nªºªvÀø¤èªkªº»Ý¨D³Ì¤j¥¼±o¨ìº¡¨¬¡¦ ¥Í¬¡½è¶q¡C Fezakinumab ÁÙÅã¥Ü¥X¨}¦nªº¦w¥þ©Ê©M¥¿Åªº¤£¨}¨Æ¥ó¡AªvÀø²Õ¤§¶¡ªº¬ã¨s¤¤¤î²v¬Û¦ü¡C ÁöµM³Ìªñ§å㪺°w¹ï TH2 «H¸¹¶Ç¾Éªº dupilumab Åã¥Ü¥X¨}¦nªº¦w¥þ©Ê¡A¦ý«Ü¤j¤@³¡¤À±wªÌªí²{¥X¤£¨¬ªº¤ÏÀ³¡A ¨Ã¥B¥i¯à¨ü¯q©ó°w¹ï´À¥N³~®|ªºªvÀø¡A¨Ò¦p TH22/IL-22 ²ÓM¦]¤l³~®|¡C Discussion This is the first clinical trial investigating IL-22 blockade in patients with AD, and the first to suggest a pathogenic role of IL-22 in any human disease. Fezakinumab treatment in adults with moderate-to-severe AD resulted in consistent improvements in clinical and molecular disease scores as compared with placebo. At week 12, significant clinical improvements in drug-treated compared with placebo-treated patients were best seen in severe AD patients (baseline SCORAD ≥50). Moreover, progressive improvements in all outcome measures were observed until week 20, which was 10 weeks after the last dose, suggesting sustained drug responses beyond end of treatment. This study is the first evidence in humans that, similar to the TH2 cytokines IL-4 and IL-13,6, 7, 15, 16 IL-22 is a key driver of AD. Whereas current monoclonal antibody treatment approaches approved or currently being tested in drug trials target the TH2 pathway in AD,6, 19, 20, 21 these data provide a completely new mechanism for future therapeutic strategies for AD and other disease where IL-22 might have a role, such as pediatric psoriasis14 or pediatric AD.22 Larger and more significant differences were specifically seen in the severe AD patient group. Possible reasons for reduced statistical significance in the moderate AD cohort might be higher variability and lower maximal differences because of lower baseline disease. Patients with severe AD start with higher disease severity and often show less fluctuations, allowing for greater differences in treatment responses.23, 24, 25, 26, 27 The sensitivity of clinical outcome measures generally increases with higher baseline disease activity and shows less reproducibility with lower scores,23, 24, 25, 26, 27 a fact that is now increasingly recognized in trial design. Our study has several limitations. First, our study was designed >6 years ago, and only used SCORAD to measure disease severity, similar to many studies designed at the time,17 while current AD trials often use Eczema Area and Severity Index (EASI) scores as primary outcomes, limiting the ability to compare with other clinical trials. Nevertheless, recent studies considered both measures, and in these studies, SCORAD appears to be a more stringent disease measure; changes in EASI scores tend to be much larger than respective SCORAD changes.6, 7 Second, our study was designed before emerging data that AD is a heterogeneous disease,22, 28, 29, 30 which necessitates a study design allowing for analyses of subset populations. To address this, we used a post-hoc analysis approach separating patients with severe from moderate disease. Larger studies are needed to compare with other treatments and to confirm efficacy in AD subgroups (eg, moderate vs severe disease, different ethnicities). This study, supported by progressive clinical improvements with IL-22 antagonism versus placebo, reveals a novel therapeutic paradigm for AD, and particularly severe AD, a population that presents the largest unmet need for better therapeutics due to its debilitating nature and devastating effects on patients¡¦ quality of life.31 Fezakinumab also showed a favorable safety profile with balanced adverse events, and similar study discontinuation rates between treatment arms. While the recently approved dupilumab, which targets TH2 signaling, shows a good safety profile, a large subset of patients show insufficient responses,6 and might benefit from treatment directed at an alternative pathway, such as the TH22/IL-22 cytokine pathway. www.jaad.org/article/S0190-9622(18)30101-4/fulltext ORIGINAL ARTICLE| VOLUME 78, ISSUE 5, P872-881.E6, MAY 01, 2018 Efficacy and safety of fezakinumab (an IL-22 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by conventional treatments: A randomized, double-blind, phase 2a trial Emma Guttman-Yassky, MD, PhD--------- clinicaltrials.gov/ct2/show/study/NCT01941537 Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/12 ¤U¤È 05:06:58²Ä 4879 ½g¦^À³
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¯S´µ©Ô5¦ì¦@¦P³Ð¿ì¤H ¬°¤°»ò¥u¦³³o2¤Hµo¤j°]¡H 2021-11-12 15:19 ¸gÀÙ¤é³ø / ½sĶ©u´¹´¹¡þºî¦X¥~¹q ¯S´µ©Ô¡]Tesla¡^°õ¦æªø°¨´µ§J¥»©P¥X²æªÑ²¼®M²{50»õ¬ü¤¸¡A¤Þµo¥þ²yÃöª`¡A´I¤ñ¤h¡]Fobes¡^Âø»x±Ä³X¤F¯S´µ©Ô¦@¦P³Ð¿ì¤H¤Î«e°õ¦æªøMartin Eberhard¡A¸ß°Ý¥L¹ï³o®a¹q°Ê¨®¤j¼t¥«È¬ð¯}1¥ü¬ü¤¸ªº¬Ýªk¡Aµo²{¥L©M¨ä¥L¦@¦P³Ð¿ì¤H¨S¯à¸òµÛ°¨´µ§J¦¨¬°»õ¸U´I»¨ªº¥D¦]¬O¡A¥L̫ܦ´N½æ±¼¯S´µ©ÔªºªÑ²¼¡C ºë³q§Þ³NªºMartin Eberhard¨Ã¥¼¦¨¬°¯S´µªº¥N¦Wµü¡A¤]»P¥þ²yº´Iªº¦a¦ì¥¢¤§¥æÁu¡C¥L»¡¡G¡u§Ú«Ü¤[¥H«e´N½æ±¼«Ü¤j¤@³¡¤ÀªºªÑ²¼¡C¤j®a¦b§Ú³Ð¿ì¯S´µ©Ô®É¥H¬°§Ú¬O»õ¸U´I¯Î¡C¦ý§Ú¤£¬O¡C¡v 2007¦~¡A¦bRoadster±À¥X¤§«e¡AEberhard¥X°â¤j³¡¤À«ùªÑ¡A³Ì²×³QÀ½¥X¯S´µ©Ô¡C2009¦~¡A¥L¥H½ÚÁ½©M³Q»°¤U¥x¬°¥Ñ±±§i°¨´µ§J¡A³Ì²×¹F¦¨®x¥~©M¸Ñ¡A¥H¤¹³\°¨´µ§J©M¨ä¥L¤H¦ÛºÙ³Ð¿ì¤H¬°¥æ´«¡A¨ä¥L±ø¥ó«h¥¼©ÜÅS¡C ¥L»¡¥L¦bÂ÷¶}¯S´µ©Ô«á°]°Èª¬ªp«Ü¤£¦n¡A¤£³Q¤¹³\¤u§@ªø¹F¤@¦~¡A·í®É¡u¯uªº¨µL¤À¤å¡v¡C¥LÂ÷¶}«á¤]¨S¦A°Ñ¥[¥ô¦ó¤@½üªº¿Ä¸ê¡C °¨´µ§J±N¥L¦bPayPalÁȪº¿ú§ë¤J¯S´µ©Ô°µ¬°ºØ¤l¸êª÷¡A³Ì²×űo¸Ó¤½¥qªº±±¨îªÑÅv¡C¥Lªº«ùªÑ¤£Â_¼W¥[¡A¦]¬°¥L¿ï¾Ü¨C©u»â¨úªÑ²¼¿ï¾ÜÅv¡A¦Ó«DÁ~¸ê¡C °£°¨´µ§J©MEberhard¥~¡A¯S´µ©Ôªº¨ä¥L3¦ì³Ð¿ì¤HÁÙ¥]¬A¦´Áªº¤@¦ì¤uµ{®vIan Wright¡Bª¿¨¦³Ð§ë¤½¥qSpero Ventures¦X¹Ù¤HMarc Tarpenning¡A©M2019¦~Â÷¾ªº«e§Þ³NªøJB Straubel¡C ¥Ø«e¬Ý¨Ó¡A¥u¦³JB StraubelÁÙ¥i¯à¦¨¬°»õ¸U´I¯Î¡A°²¨Ï¥L«O¯dÂ÷¾®Éªº«ùªÑ¡A¦ôp¦p¤µªº»ùÈ¥i¯à°ª¹F13»õ¬ü¤¸¡CTarpenning¾Ö¦³¤@¨Ç¯S´µ©ÔªÑ²¼¡A¦ý¤£¬O¤jªÑªF¡CWright«h¨S¦³¥ô¦ó¯S´µ©ÔªÑ²¼¯d¤U¨Ó¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/10 ¤U¤È 09:58:45²Ä 4878 ½g¦^À³
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MENLO PARK, Calif. and SINGAPORE, Nov. 10, 2021 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (Nasdaq:ASLN), a clinical-stage immunology focused biopharmaceutical company developing innovative treatments to transform the lives of patients, today announced Dr Carl Firth, CEO, will participate in-person at the 12th Annual Jefferies London Healthcare Conference on November 17, 2021, at 1:00pm GMT. The conference will be held in-person November 16 and 17, 2021 and virtually November 18 and 19, 2021. ¥[§QºÖ¥§¨È¦{ªù¬¥©¬§J©M·s¥[©Y¡A2021 ¦~ 11 ¤ë 10 ¤é¡]¥þ²y·s»D³q°TªÀ¡^--ASLAN Pharmaceuticals¡]¯Ç´µ¹F§JªÑ²¼¥N½X¡GASLN¡^¬O¤@®a±Mª`©óÁ{§É¶¥¬q§K¬Ì¾Çªº¥Íª«»sÃĤ½¥q¡AP¤O©ó¶}µo³Ð·sÀøªk¥H§ïÅܱwªÌªº¥Í¬¡¡A¤µ¤Ñ«Å¥¬ Carl Firth ³Õ¤h º®u°õ¦æ©x¡A±N©ó 2021 ¦~ 11 ¤ë 17 ¤é®æªL«Âªv¼Ð·Ç®É¶¡¤U¤È 1 ÂI¿Ë¦Û°Ñ¥[²Ä 12 ©¡³Ç´I·çÛ´°ÂåÀø«O°·¦~·|¡C ¸Ó·|ij±N©ó 2021 ¦~ 11 ¤ë 16 ¤é¦Ü 17 ¤é¥H¤Î¹ê»Ú¤W©ó 2021 ¦~ 11 ¤ë 18 ¤é¦Ü 19 ¤é¿Ë¦ÛÁ|¦æ¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/10 ¤U¤È 07:17:14²Ä 4877 ½g¦^À³
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www.marketwatch.com/investing/stock/amgn?mod=over_search AMGN : AMGEN ¤½¥qªÑ²¼¥«È1190»õ¬ü¤¸. ¨ÖÁÊASLNè¦n¦Ó¤w. 2021¦~Q3À禬67»õ¬ü¤¸.//2021¥þ¦~¦ô 258~262»õ¬ü¤¸. 2021 Guidance For the full year 2021, the Company now expects: • Total revenues in the range of $25.8 billion to $26.2 billion. investors.amgen.com/static-files/a97dc0af-43ae-4486-b9ad-5f6224b19010 AMGEN REPORTS THIRD QUARTER 2021 FINANCIAL RESULTS THOUSAND OAKS, Calif. (November 2, 2021) - Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2021. Key results include: • Total revenues increased 4% to $6.7 billion in comparison to the third quarter of 2020, driven by higher unit demand, partially offset by lower net selling prices. ◦ Product sales increased 4% globally, driven by double-digit volume growth across a number of our products, including Prolia® (denosumab), EVENITY® (romosozumab-aqqg), Repatha® (evolocumab) and MVASI® (bevacizumab-awwb). • GAAP earnings per share (EPS) decreased 3% to $3.31 driven by a $400 million licensing-related expense from our collaboration with Kyowa Kirin Co., Ltd. (Kyowa Kirin), partially offset by increased revenues. ◦ GAAP operating income decreased 3% to $2.4 billion, and GAAP operating margin decreased 2.6 percentage points to 37.6%. • Non-GAAP EPS increased 11% to $4.67 driven by increased revenues and the impact of fewer weighted average shares outstanding. Total non-GAAP operating expenses increased less than 1%. ◦ Non-GAAP operating income increased 8% to $3.5 billion, and non-GAAP operating margin increased 2.5 percentage points to 54.6%. • The Company generated $2.2 billion of free cash flow in the third quarter versus $3.2 billion in the third quarter of 2020, driven by higher collections in the third quarter of 2020 from customers who had been granted extended payment terms due to COVID-19. This increase was partially offset by the timing of tax payments in the third quarter of 2020. • 2021 total revenues guidance of $25.8-$26.2 billion; EPS guidance of $9.55-$10.21 on a GAAP basis and $16.50-$17.10 on a non-GAAP basis. Our newest product, LUMAKRAS® , a first-in-class lung cancer treatment, is off to a strong start and our robust pipeline of potential new medicines across all stages of development sets us up well to drive growth over the long term, said Robert A. Bradway, chairman and chief executive officer. We achieved solid growth in the quarter as our medicines reached an increasing number of patients around the world. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/10 ¤U¤È 06:59:49²Ä 4876 ½g¦^À³
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KHK4083 + ASLAN004 ---Âù¼Ð¹vªºAD+ý³ÝÁ{§É ¤£¬O¤£¥i¯à. KHK4083 2b AD ¬ã¨sªºº®u¬ã¨sû¡B¨t²Î¥D®u Emma Guttman-Yassky ³Õ¤h ©M ASLN ¦X§@ASLAN004 ¥Íª«¼Ð»x 2B ADÁ{§É. «Ü¦h·Q¹³! |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/11/10 ¤U¤È 01:27:19²Ä 4875 ½g¦^À³
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¤½¥q¬Oª±¯uªº¡A¨S¤°»ò¦nÃhºÃªº §ä¥X§¹³ÓDupilumabªºMOA´N¦¨¥\¤F ¥[ªo¡A¦Ñ·à¡A¨ì®É¤~¯àÅý¨º¨ÇÁ@¤£°_§A ªº¨º¨Ç¤H¡A©ïÀY¥õ±æµÛ§A¡A¦Ó»»¤£¥i¤Î |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/10 ¤U¤È 12:46:42²Ä 4874 ½g¦^À³
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Emma Guttman-Yassky ³Õ¤h¥ç¬O¤é¥»ÄQÅï KHK4083 2b AD ,Á{§É¬ã¨sªºº®u¬ã¨sû¡B¨t²Î¥D®u. ¬Ý¨ÓILL22 ¦³»P AD°£IL4/IL13¥~, ªºÃö³s¥i¯à©Ê¤j. ¤]³\IL22ªº ¨ü¾¹¬O¥Dn¼Ð¹v. ASLAN004 2b ¥ý¤F¸Ñ¬O§_IL22 ©MÀø®Ä¦³Ãö«Y. 1.ASLAN ¤µ¤Ñ¡A§ÚÌ«Å¥¬»PµÛ¦Wªºª¢¯g©Ê¥Ö½§¯f±M®a Emma Guttman-Yassky ³Õ¤h¦X§@¶}®i¬ã¨s¡A¸Ó¬ã¨s±N¦b ASLAN ªº 2b ´Áp¹º¤¤Ä~Äò¶i¦æ¡A¥HÃѧO©Mªí¼x ASLAN004 ¹ï¯e¯f¬ÛÃö¥Ö½§©M¦å²M¥Íª«¼Ð»xª«(IL22)ªº¼vÅT ±w¦³¤¤«×¦Ü««×¯SÀ³©Ê¥Öª¢ (AD) ªº¦¨¤H¡C Today, we announced a collaboration with renowned inflammatory skin disease expert Dr Emma Guttman-Yassky, MD PhD, to conduct research that will continue throughout ASLAN¡¦s Phase 2b program to identify and characterize the effects of ASLAN004 on disease-associated skin and serum-biomarkers in adults with moderate-to-severe atopic dermatitis (AD). 2021/10/20 aslanpharma.com/app/uploads/2021/10/ASLAN-Pharmaceuticals-Announces-Scientific-Collaboration-With-Dr-Emma-Guttman-Yassky-on-Identification-of-ASLAN004-specific-Biomarkers-.pdf ------------------ 2.¤é¥»ÄQÅï KHK4083 ¡¨¸Ó¬ã¨sªºº®u¬ã¨sû¡B¨t²Î¥D®u Emma Guttman-Yassky ³Õ¤h»¡ KHK4083 2 ´Á¬ã¨sªºµ²ªGªí©ú¡AOX40 ¬O¯SÀ³©Ê¥Öª¢ªº¬ÛÃö¹vÂI¡A¥i¯à·|´£¨Ñ¤@ºØ·sªºªvÀø½d¦¡¡A ¡¨¸Ó¬ã¨sªºº®u¬ã¨sû¡B¨t²Î¥D®u Emma Guttman-Yassky ³Õ¤h: ¦è©`¤s¥ì§¢Âå¾Ç°|¥Ö½§¯f¾Ç¨t©M Waldman ¥Ö½§¯f¾Ç©M§K¬Ì¾Ç±Ð±Â¡BÀã¯l¨ô¶V¤¤¤ß¥D¥ô©M¦è©`¤sª¢¯g©Ê¥Ö½§¯f¹êÅç«Ç¥D¥ô¡C The results of the KHK4083 Phase 2 study show that OX40 is a relevant target for atopic dermatitis and may provide a new treatment paradigm,¡¨ said the lead investigator of this study, Dr. Emma Guttman-Yassky, MD./PhD., System Chair for the Department of Dermatology and Waldman Professor of Dermatology and Immunology, Icahn School of Medicine at Mount Sinai and Director of the Center for Excellence in Eczema, and the Laboratory of Inflammatory Skin Diseases at Mount Sinai. www.businesswire.com/news/home/20210218005535/en/Kyowa-Kirin-Announces-Positive-Phase-2-Results-for-KHK4083-in-Patients-with-Moderate-to-Severe-Atopic-Dermatitis The results of the KHK4083 Phase 2 study show that OX40 is a relevant target for atopic dermatitis and may provide a new treatment paradigm,¡¨ said the lead investigator of this study, Dr. Emma Guttman-Yassky, MD./PhD., System Chair for the Department of Dermatology and Waldman Professor of Dermatology and Immunology, Icahn School of Medicine at Mount Sinai and Director of the Center for Excellence in Eczema, and the Laboratory of Inflammatory Skin Diseases at Mount Sinai. ¡§In addition to the primary endpoint, this study also showed progressive improvement in efficacy by continuous KHK4083 administration beyond 16 weeks and the potential for long-term sustained therapeutic effect after the completion of KHK4083 treatment.¡¨ ¡§We are very pleased with the results of this study assessing efficacy and safety of KHK4083 in chronic, recurrent, moderate to severe atopic dermatitis,¡¨ said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of Global R&D Division of Kyowa Kirin. ¡§We look forward to sharing the results of the full analysis in the near future. I would like to express my deep gratitude to the medical professionals and patients for their participation in the study. We will continue KHK4083 development with the hope it can help patients in need.¡¨ |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/9 ¤U¤È 04:53:12²Ä 4873 ½g¦^À³
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investor.regeneron.com/static-files/fe9d17bb-38cc-4a2c-b96c-dbc4a79d072e REGN 2021¦~11¤ë ¤½¥q²³ø Dupilumab II«¬ª¢¯g ¬ü°ê¥Ø¼Ð¥«³õ ¤w¤W¥«AD 230¸U+ý³Ý97.5¸U+CRSwNP 9¸U¤H=336.5¸U¤H ¥¼¨Ó4¦~,6ºØ¾AÀ³¯gªº¤W¥«p¹º80¸U¤H ¤pp: ¬ü°ê¥Ø¼Ð«È¤á413¸U¤H ---¥Ø«e¬°¤î¤w¶}¥ß¬ü°ê³B¤èÅÒ27¸U¤H,¬ü°ê¥«³õº¯³z²v6.5% 2021¦~,«e¤T©u²Öp44»õ¬ü¤¸, ¥þ¦~¦ô62~63»õ¬ü¤¸¾P°â. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/8 ¤U¤È 08:45:08²Ä 4872 ½g¦^À³
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2021/11/08 05:30 ºÊºÞ®Ø¬[²Ó¸` ¦~©³«e¥i±æºV©w ¡e½sĶ¿c¥Ã¤s¡þºî¦X³ø¾É¡fµØº¸µó¤é³ø³ø¾É¡A¬ü°êÃÒ¨é¥æ©ö©eû·|¡]SEC¡^¤é«e§åã¤@¶µºÊºÞ®Ø¬[¡A¦b¬ü¤W¥«ªº¤¤°ê¥ø·~Y¥¼³q¹L¼fpÀˬd¡A±N¾D°Ç¥O¤U¥«¡A¥Ø«e¬ù¦³¤G¤C¡³®a¤¤¥ø¦b¬ü¤W¥«¡A³o¨Ç¤¤¥ø³£¥¼²Å¦X¬ü°ê¼fp³W½d¡CSEC¥D®u¸â´µ°Çªí¥Ü¡A³o¶µºÊºÞ®Ø¬[¥i±æ¦b¤µ¦~©³«eºV©w²Ó¸`¡AÀH«á±N±Ò°Ê¤¤¥ø¤U¥«µ{§Ç¡C Y¥¼³q¹L¼fpÀˬd ±N°Ç¥O¤U¥« ¬ü°ê°ê·|¥h¦~¤Q¤G¤ë³q¹L¡u¥~°ê¤½¥q°Ý³dªk¡v¡ASEC¤µ¦~¤T¤ëµo§GÁ{®É¹ê¬I±ø¨Ò¡A©ú©w¦b¬ü¤W¥«ªº¥~¥ø¡AY¨ä¼fp¤½¥q³sÄò¤T¦~¤£±µ¨ü¬ü°ê¤W¥«¤½¥q·|pºÊ·þ©eû·|¡]PCAOB¡^¼f¬d¡A³o¨Ç¥~¥ø±N³QSEC°Ç¥O¤U¥«¡C ¥Ø«e¦b¬ü¤W¥«¤¤¥ø ³£¥¼²Å³W½d SEC¤¤é¤½§i¡A¤w§åãPCAOBªº¤»¤@¡³¡³±ø³W«h¡A§Y¡u¥~°ê¤½¥q°Ý³dªk¡v¬I¦æ²Ó«h¡An¨DPCAOB½T©w¨ä¬O§_¦]¬°¥~°ê¥qªkºÞÁÒ°Ï·í§½±Ä¨ú¥ß³õ¡A¦ÓµLªk¼f¬d¦ì©ó¥~°ê¥qªkºÞÁҰϪºµù¥U·|p®v¨Æ°È©Ò¡A¨Ã³W©w±Nþ¨Ç°T®§©M¤å¥ó¥Î©óµû¦ô¥~¥ø¬O§_²Å¦X¬ü°êÃÒ¨éªkªº¬yµ{¡A¨Ã¤¹³\PCAOB§P©w¡A¬O§_»ÝnIJµo¤W¥«¤½¥qªº°£µPµ{§Ç¡C ¸â´µ°Çªí¥Ü¡A³o¬O«OÅ@¬ü°ê§ë¸ê¤Hªº«n¤@¨B¡ASEC±N»PPCAOB¦@¦P§V¤O¡A½T«O¶i¤J¬ü°ê¸ê¥»¥«³õªº¥~¥ø¡A¨ä¼fp¤½¥q¯à¿í¦u¬Û¦P³W©w¡C PCAOB¨C¤T¦~¹ï¥|¤Q¦hÓ¥qªkºÞÁҰϪº¤G¡³¡³¦h®a«D¬ü°ê¼fp¤½¥q¶i¦æÀˬd¡A¦ý¦]µLªk¨ú±o¤¤°ê¬ÛÃö³¡ªù§åã¡APCAOB¤£¯àÀˬd¤¤¥øªº¼fp¤å¥ó¡CSEC¦¹Á|Àò±o¬ü°ê¾÷ºc§ë¸ê¤H¨ó·|ºÙ³\¡A»{¬°±Ò°Ê¬Y¨Ç¥~¥ø¤U¥«µ{§Ç¡Aµu´Á¤ºÁöµM·|³y¦¨§ë¸ê¤H·l¥¢¡Aªø´Á¦Ó¨¥¦³§Q©ó¬ü°ê¸ê¥»¥«³õ¡C news.ltn.com.tw/news/world/paper/1483262 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/8 ¤U¤È 08:29:17²Ä 4871 ½g¦^À³
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CNTB ì¨Ó¥i¯à³Q¬ü°ê¤U¥«. ---------------------------------- ¥Ø«e¬ù270®a¤¤¥ø¦b¬ü±¾µP¥æ©ö¡AµL¤@®a²Å¦X¬ü°ê¼fp³W½d¡C ----------------------------- tw.stock.yahoo.com/news/%E7%BE%8E%E5%9C%8Bsec%E6%89%B9%E5%87%86%E7%9B%A3%E7%AE%A1%E6%A1%86%E6%9E%B6-270%E5%AE%B6%E6%9C%AA%E9%80%9A%E9%81%8E%E5%AF%A9%E8%A8%88%E6%AA%A2%E6%9F%A5%E4%B8%AD%E4%BC%81%E6%81%90%E8%A2%AB%E8%BF%AB%E4%B8%8B%E5%B8%82-090726995.html ¬ü°êSEC§åãºÊºÞ®Ø¬[¡A270®a¥¼³q¹L¼fpÀˬd¤¤¥ø®£³Q¢¤U¥« 2021¦~11¤ë8¤é ¶g¤@ ¤U¤È5:07 ¡i°]°T§Ö³ø¡þªL¯E³Õ¡j¡mµØº¸µó¤é³ø¡n³ø¾É¡A¬ü°êÃÒ¨é¥æ©ö©eû·|(SEC)¤é«e§åã¤@¶µºÊºÞ®Ø¬[¡A¦b¬ü¤W¥«¤¤°ê¥ø·~¦p¥¼³q¹L¼fpÀˬd¡A±N¾D±j¨î¤U¥«¡A ¥Ø«e¬ù270®a¤¤¥ø¦b¬ü±¾µP¥æ©ö¡AµL¤@®a²Å¦X¬ü°ê¼fp³W½d¡CSEC¥D®u¸â°Ç´µªí¥Ü¡A³o¶µ®Ø¬[¥i±æ¦~©³«eºV©w²Ó¸`¡AÀH«á´N±Ò°Ê¤U¥«µ{§Ç¡C |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/11/6 ¤W¤È 07:08:50²Ä 4870 ½g¦^À³
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¨S¿ù¡A´Nı±o¸z¯f¤]¬O«Ü¤jªº¥«³õ ±q¨Ãä¬Ý¨ì¡AÅ¥¨ìªº´N¤ñ¥Ö½§ª¢¦hªº¦h ©ú¦~ªì·|¤£·|¦]¬°003ªº®ø®§¡A¤S¬O¤@³õ µØÄRªº·Ï¤õ¨q «e°}¤l¤j¶^®É¡A·Pı¥[½Xªº¤Ö¤F |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2021/11/5 ¤U¤È 10:17:52²Ä 4869 ½g¦^À³
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IBD¥«³õ¨ì2028¦~278»õ¬ü¤¸¤ñAD¥«³õÁÙ¤j (ªvÀøAD,IBDÃĪ« ³£¬O¤jÃÄ¡A200»õ¬ü¤¸°_¸õ) The global inflammatory bowel disease treatment market size is expected to reach USD 27.8 billion by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 4.8% from 2021 to 2028 ªvÀøAD»P®ð³ÝªºASLAN004»PªvÀøIBDªºASLAN003 ±NÀH¤G´ÁÁ{§Éªº®i¶}¡A³v¨B±À¤É¨ä»ùÈ¡A²Ö¿n³Q¨ÖÁʪº¨»ù¡C www.grandviewresearch.com/press-release/global-inflammatory-bowel-disease-ibd-treatment-market?utm_source=blog.goo.ne.jp&utm_medium=referral&utm_campaign=Vrushali_7Aug_hc_InflammatoryBowelDiseaseTreatmentMarket_pr&utm_content=Content |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2021/11/5 ¤U¤È 09:53:45²Ä 4868 ½g¦^À³
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¬õ¹Ð¤j ¤½¥q¤½¥¬ASLAN003©ú¦~ªì¶i¦æIBD¤G´ÁÁ{§É´N¤£·|±q1b°µ°_, ASLAN003 ¤w°µ¹L«æ©Ê°©Åè©Ê¥Õ¦å¯f¤G´Á , ¦pÂà´«¾AÀ³¯g®Éª½±µ±q¤G´Á¶i¦æ ( ¦P¤@ºØÃĪ« ) Inflammatory bowel disease, ÁY¼g¡GIBD¡A¬O¤@²Õ¯S©wªº¸z¹DºC©Ê¯e¯fªº²ÎºÙ¡A¥Dn¥]¬A§J¶©¤ó¯g©M¼ìºÅ©Êµ²¸zª¢¡C IBDªvÀø ¥«³õ2026¦~±N¹F224»õ¬ü¤¸¡C4.4%¦~¦¨ªø²v(2019-2026) IBD Treatment Market Size Worth $22.4 Billion By 2026 CAGR: 4.4% ( ¤Ñ©R¤j 2021/7/14 ¤À¨É ) |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/5 ¤U¤È 08:27:56²Ä 4867 ½g¦^À³
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¥i¥³°Ñ¦Ò CNBT CBP-307 ,¤@¼Ë¤fªA, A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC) www.clinicaltrials.gov/ct2/show/NCT04700449?term=CBP-307&draw=2&rank=1 Detailed Description: This is a multicenter, multicountry, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC). CBP-307 capsules are administered orally. This study includes stage 1 and stage 2. After screening, subjects will enter the randomized, double-blind, placebo-controlled induction therapy for 12 weeks, i.e., the study stage 1. All subjects who complete 12 weeks of induction therapy (with CBP-307 or placebo) in the study stage 1 and complete all examinations (including colonoscopy) at the week 12 visit can choose to enter the study stage 2 of a total of 40 weeks, including 36 weeks of continuous administration and 4 weeks of safety follow-up after the last dose. Study Design Go to sections Study Type : Interventional (Clinical Trial) Estimated Enrollment : 134 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC) Actual Study Start Date : February 27, 2019 Estimated Primary Completion Date : December 2021 Estimated Study Completion Date : September 2022 Crohn¡¦s disease (CD) is an inflammatory bowel disease (IBD) that causes chronic inflammation of any site in the gastrointestinal tract, but most commonly affects the small intestine and beginning of the large intestine. It is estimated that in 2015 there were 3.1 million U.S. adults with a diagnosis of IBD.1 In North America, CD has a slightly lower prevalence than Ulcerative colitis, which is the other type of IBD.2 Current treatment options include systemic corticosteroids as first-line therapy and a variety of biologics as second- and third-line therapy.4 There is significant need for orally available therapies that can safely and effectively address unmet need for patients with Crohn¡¦s disease, especially those with severe disease.5 www.connectbiopharm.com/pipeline/cbp-307/ |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/11/5 ¤U¤È 07:46:30²Ä 4866 ½g¦^À³
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ºâºâ®É¶¡004ªº2b¤]¸Ó¥¿¦¡¦¬²Ä¤@§å¯f±w ¶}©l¶i¦æÁ{§É¤F ¤½¥q¤½¥¬©ú¦~ªìªº003²Ä¤G¶¥¬qÁ{§É ·|¤£·|¬O«ü±q1b°µ°_¡A¦]¬°³£¨S¦³ ¤½¥¬1bªºÁ{§É¼Æ¾Ú ¦Ó²Ä¤@¶¥¬q¥u¬OÃþ¦ü¹êÅç«Çªº¹êÅç¡A¤£¬O«Ü ¥¿¦¡ªºÁ{§É |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/5 ¤U¤È 05:51:17²Ä 4865 ½g¦^À³
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finance.yahoo.com/quote/ASLN/ ¬üªÑ¥N¸¹¡GASLN §ä§Aªº¨é°Ó¡A¶}¬üªÑ±b¤á,¶i¦æ¶R½æ¡C |
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·|û¡GADAS10151414 µoªí®É¶¡:2021/11/5 ¤U¤È 05:31:35²Ä 4864 ½g¦^À³
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6497F-¨È·à±d ¤½¶}µo¦æ¤½¥q.¤£Ä~Äò¤½¶}µo¦æ¡I ¤½¶}¥«³õ¨S¦³¥æ©ö n¨ì¥¼¤W¥«¥«³õ¶R½æ¶Ü? |
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·|û¡G¸Ø±i10133098 µoªí®É¶¡:2021/11/5 ¤U¤È 12:40:27²Ä 4863 ½g¦^À³
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1.ASLN 004 ¦b9¤ë27¤é¸Ñª¼1bÂX¼W©Ê¸ÕÅç¡C a.©Ò¦³Ãļt¤w¸g¥i¥Hpµe¦p¦ó¨Ö¤UASLAN¡B b.¥ô¦ó¤@®aÃļt¦pªG¥u·Qn±ÂÅv«D¬ü¦a°Ï¡AASLAN¤£·|¦P·N¡C ASLAN·|´£¥X¥þ²y±ÂÅv¨Ó§l¤Þ¼t°Ó¥Ø¥ú¡C(¥þ²y±ÂÅv¥u¬O»ç¡A³o¼ËASLANªº½Í§P¨ÖÁÊÄw½X¤~·|¤j) 2.¦pªG004¯uªº«Ü¦³Ävª§©Ê¡A1bÂX¼W©Ê¸ÕÅç¸Ñª¼«á(§t2´ÁÁ{§É´Á¤¤³ø§i¥X¨Ó)¨ì2´Á Á{§É¸Ñª¼«e¡A·Q¨ÖASLANªºÃļt·|ºÎ¤£¦wÃ(µ¥¶V¤[¶V¾á¤ß³Q·m¿Ë)¡C 3.(«ÀYÀ¸¨Ó¤F)2´ÁÁ{§É¸Ñª¼«e¤@Ó¤ë¡AASLANnÄw3´ÁÁ{§É¸g¶O¡A¤@©wn¥þ²y±ÂÅv µ¹Ãļt¥H«KÄw¿ú¡A¨ä¥LÃļt¬Ý¨ì³Ì¬üªº¤@¶ô¦×(¥þ²y±ÂÅv)n³Q±ÂÅv¥X¥h¡A ³Q¢¤@©w·QºÉ¿ìªk¨ÖASLAN¡C(©Ò¦³Ãļt³£ª¾¹DASLANª¾¹D2´Á¸Ñª¼¼Æ¾Ú¬O¥¿¦V¡A¤]ª¾¹D§ùÁת¢ªº¾P°âÃB) 4.ý³Ý©M003ªº2´ÁÁ{§É¥u¬OASLAN³Q¨Öªº½Í§PÄw½X¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/5 ¤U¤È 12:03:01²Ä 4862 ½g¦^À³
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¥xÁÞ¤j ASLAN004 VS ¹ï·Ó²Õ ¤@.¼ÒÀÀ 2b N=60:60 ¤H IGA 0,1 , 44% VS 15% ,P=0.00049 (¤H¼Æ·U¦h,PÈ·U¤p) Dupilumab ¤@´Á*12¶g, N=55:54 , ¡«á IGA 0,1 =40% VS 7% P<0.001 www.nejm.org/doi/full/10.1056/nejmoa1314768 ) ¼ÒÀÀ DUPILUMAB N:16:13 IGA 0,1 =40% VS 7% ,P=0.10(¤H¼ÆÁY¤p29¤H,Dupilumab ¤@¼Ë¹L¤£¤F,p>0.05) ¤G.1B-RITT N=16:13¤H IGA 0,1 , 44% VS 15% ,P=0.107 ir.aslanpharma.com/static-files/da4bc98e-9b9d-4add-8d6b-b66b427f76e8 P.20 |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2021/11/5 ¤W¤È 11:23:48²Ä 4861 ½g¦^À³
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dupilumab ¤£¬O¬Ùªoªº¿O¡A¤£¯à»´¼Ä¡A£¸´ÁÁ{§É12¶gÀø®ÄPȳ£¦³¹F¼Ð¡AASLAN004¦bIGA 0/1RITT¤K¶g¨Ã¥¼¹F¼Ð¡A³o¬O³Ìȱoª`·N¦a,ÁÙ¦nEASI50,EASI75¦³¹F¼Ð¡A¦w¥þ©Ê¤S°ª¡A«O¦s®e©ö¡A£¸Ó¤ë¬I¥´£¸¦¸¦pªGÀø®Ä¤£¿ùªº¸Ü·|«Ü¦³Ävª§¤O¡C www.nejm.org/doi/full/10.1056/nejmoa1314768 |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/4 ¤U¤È 09:51:51²Ä 4860 ½g¦^À³
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Dupilumab ©ú¦~/2022¦~,¾P°â¦ô90»õ¬ü¤¸, «á¦~/2023¦~,¾P°â¦ô120»õ¬ü¤¸ Regn ¤½¥q, «D±`¥i¯à¦A±NDupilumab ³Ì°ª°â¹w´ú±q120»õ¬ü¤¸/¦~, ½Õ°ª¨ì180~200»õ¬ü¤¸/¦~. Dupilumab Q3°]³ø¥XÄl Q3³æ©u½æ16.63»õ¬ü¤¸,¥»¦~²Öp¦ÜQ3 ¾P°â44.25»õ¬ü¤¸,¦~¾P°â¦¨ªø54%. ¥h¦~¥þ¦~¾P°â½æ40.4»õ¬ü¤¸¡A¤µ¦~¦ô61~62»õ¬ü¤¸¡C investor.regeneron.com/news-releases/news-release-details/regeneron-reports-third-quarter-2021-financial-and-operating |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/4 ¤U¤È 09:32:54²Ä 4859 ½g¦^À³
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Dupilumab Q3°]³ø¥XÄl Q3³æ©u½æ16.63»õ¬ü¤¸,¥»¦~²Öp¦ÜQ3 ¾P°â44.25»õ¬ü¤¸ ¥h¦~¥þ¦~¾P°â½æ40.4»õ¬ü¤¸¡A¤µ¦~¦ô61~62»õ¬ü¤¸¡C investor.regeneron.com/news-releases/news-release-details/regeneron-reports-third-quarter-2021-financial-and-operating -------------------------------------- Dupixent /Dupilumab ³æ¦ì:¦Ê¸U¬ü¤¸ USA(¬ü°ê)// ROW (¨ä¥L°Ï°ì)//¤pp 2021 Q1 961.5 //301.4//1262.9 Q2 1140//352//1492 Q3 1256.7//406.2//1662.9 Q4 ¦Xp 3364.8//1060//4424.8 2020 Q1 679.0 174.2 853.2 Q2 770.4 176.6 947.0 Q3 851.2 221.4 1072.6 Q4 925.6 246.4 1172.0 ¤pp3226.2 818.6 4044.8 2019 Q1 303.0 70.7 373.7 Q2 454.7 102.6 557.3 Q3 508.3 124.8 633.1 Q4 605.2 146.3 751.5 ¤pp 1,871.2 444.4 2,315.6 2018 Q1 117.2 14.2 131.4 Q2 180.9 28.3 209.2 Q3 219.6 43.0 262.6 Q4 258.6 60.2 318.8 ¤pp 776.3 145.7 922.0 2017 Q1 ******* Q2 ******* Q3 88.5 0.5 89.0 Q4 136.9 2.0 138.9 ¤pp 225.4 2.5 227.9 2017/03/28 FDA®Öã¤W¥« |
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·|û¡G¸Ø±i10133098 µoªí®É¶¡:2021/11/4 ¤W¤È 10:07:52²Ä 4858 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/11/4 ¤W¤È 09:10:55²Ä 4857 ½g¦^À³
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FDA n¨D´NªvÀø¬Y¨ÇºC©Êª¢¯gªº JAK §í»s¾¯¤Þ°_ÄY«¤ßŦ¬ÛÃö¨Æ¥ó¡BÀù¯g¡B¦å®ê©M¦º¤`·ÀI¼W¥[µo¥Xĵ§i www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death °£¤F¦³®Ä©Ê¥H¥~ , ÃĪ«¦w¥þ©Ê¤]«Ü«n |
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ibmi.taiwan-healthcare.org/zh/news_detail.php?REFDOCTYPID=0o4dd9ctwhtyumw0&REFDOCID=0qzjyul88xy298vv 2021/09/17 ¤¤¤å³ø¾É abrocitinib monotherapy in the Janus kinase 1 (JAK1) atopic dermatitis ©M¨ä¥L¤fªAJAK1§í¨î¾¯¤@¼Ë, ¥¼¨Ó½÷·çªºªü¥¬Ã¹´À¥§/abrocitinib¤W¥«, FDA¥i¯à·|µo¥X¥ÎÃÄ(¶Â®Ø)Åå§i:¤ßŦ¯e¯f¡BÀù¯g |
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Janus kinase 1 (JAK1),¤fªA,ªvÀø-««×AD, ¤T´Á¼Æ¾Ú¥¿¦V¤½¤w¹L30Ó,ÁÙ没¦³¨ú±oÃĵý,°Æ§@¥Î¬O³Ì¤j»Ùê. ---------------------------------------------------- 28 MAY 2019 COMMENT Pfizer¡¦s abrocitinib clears first Phase III hurdle with ease US pharmaceutical company Pfizer announced the results of subjects treated with abrocitinib monotherapy in the Janus kinase 1 (JAK1) atopic dermatitis efficacy and safety (JADE) mono-1 study for the treatment of moderate-to-severe atopic dermatitis. The results were unveiled on 15 May. Atopic dermatitis treatment 2020 Patients treated with the drug experienced statistically significant improvements compared to subjects on placebo in both dosage groups in all co-primary and secondary endpoints of the randomized, double-blind, placebo-controlled, parallel-group study over 12 weeks. With results of the JADE mono-2 trial expected later this year, GlobalData anticipates abrocitinib to launch in 2020 and generate $1.5 billion in revenue by 2027 to become the leading JAK inhibitor treatment for atopic dermatitis. Abrocitinib, also known as PF-04965842, is expected to be the first JAK1-specific inhibitor treatment for atopic dermatitis. Expectations were raised when the drug received the Breakthrough Therapy designation from the US Food and Drug Administration (FDA) in February 2018, which means that preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. One benefit of this designation is the expedited development and review of the drug. This substantial improvement is reflected in the top-line results of the JADE mono-1 study, where both abrocitinib dosages met both co-primary and secondary endpoints. The co-primary endpoints consisted of a proportion of subjects achieving an Investigator¡¦s Global Assessment (IGA) score of 0 or 1 (clear or mostly clear) with an improvement of two or more points, and a proportion of subjects achieving a 75% improvement in the Eczema Area and Severity Index (EASI-75). The secondary endpoints were a proportion of subjects achieving a four-point or greater reduction in the Pruritus Numerical Rating Scale (NRS) and the magnitude of decrease in the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD). In terms of safety, the 100mg and 200mg abrocitinib dosage groups both experienced a discontinuation rate of 5.8%, compared to 9.1% in the placebo group. Key opinion leaders (KOLs) interviewed for GlobalData¡¦s Atopic Dermatitis ¡V Market Analysis and Forecasts to 2027 report had positive opinions on the drug, with most looking forward to an effective, orally administered treatment for the moderate-to-severe atopic dermatitis patient demographic. Moreover, while a few KOLs previously expressed concern over the systemic effects of JAK inhibitors impeding inflammatory signalling far upstream, these newly announced top-line results will help abate fears regarding the safety profile of abrocitinib. ¦r¤¸¨î¡G5000 2019¦~5¤ë28¤éµû½× ½÷·çªºªü¥¬Ã¹´À¥§»´ÃP²M°£¤F²Ä¤@ÓIII´Á»Ùê ¬ü°ê»sÃĤ½¥q½÷·ç¤½¥q¡]Pfizer¡^«Å¥¬¡A¦bJanus¿E酶1¡]JAK1¡^¯SÀ³©Ê¥Öª¢ªº¦³®Ä©Ê©M¦w¥þ©Ê¡]JADE¡^mono-1¬ã¨s¤¤¡A¥Îªü¥¬´À¥§³æÃĪvÀøªº¨ü¸ÕªÌªvÀø¤¤¦Ü««×¯SÀ³©Ê¥Öª¢ªºµ²ªG¡Cµ²ªG©ó5¤ë15¤é¤½§G¡C 2020¦~¯SÀ³©Ê¥Öª¢ªvÀø ¦b12¶g¤º¡A¦bÀH¾÷¡AÂùª¼¡A¦w¼¢¾¯¹ï·Ó¡A¥¦æ¤À²Õ¬ã¨sªº©Ò¦³¦@¦P¥Dn©M¦¸n²×ÂI¤¤¡A»P¦w¼¢¾¯¨ü¸ÕªÌ¬Û¤ñ¡A¦b¨âÓ¾¯¶q²Õ¤¤¡A»P¦w¼¢¾¯¨ü¸ÕªÌ¬Û¤ñ¡A¸ÓÃĪ«ªº±wªÌ²Îp¾Ç¤W§¡¦³ÅãµÛ§ïµ½¡C JADE mono-2¸ÕÅ窺µ²ªG¹wp¦b¤µ¦~±ß¨Ç®ÉÔ¡AGlobalData¹wpªü¥¬Ã¹´À¥§±N¦b2020¦~§ë©ñ¥«³õ¡A¨ì2027¦~±N²£¥Í15»õ¬ü¤¸ªº¦¬¤J¡A¦¨¬°ªvÀø¯SÀ³©Ê¥Öª¢ªº»â¥ýJAK§í»s¾¯¡C ªü¥¬´À¥§¡A¤]ºÙ¬°PF-04965842¡A¦³±æ¦¨¬°¯SÀ³©Ê¥Öª¢ªººÓJAK1¯S²§©Ê§í»s¾¯ªvÀø¡C·í¸ÓÃĪ«©ó2018¦~2¤ëÀò±o¬ü°ê¹«~©MÃĪ«ºÞ²z§½¡]FDA¡^ªº¬ð¯}©ÊÀøªkºÙ¸¹®É¡A¤HÌ´£¥X¤F´Á±æ¡A³o·N¨ýµÛªì¨BªºÁ{§ÉÃÒ¾Úªí©ú¸ÓÃĪ«¥i¯à¦b¤@өΦhӨ㦳Á{§É·N¸qªº²×ÂI¤WÅã¥Ü¥X¹ï²{¦³Àøªkªº¹ê½è©Ê§ïµ½¡C³oºØ«ü©wªº¤@Ó¦n³B¬O¥i¥H¥[§ÖÃĪ«ªº¶}µo©M¼f¬d¡C JADE mono-1¬ã¨sªº³Ì°ªµ²ªG¤Ï¬M¤F³oºØ¹ê½è©Êªº§ïµ½¡A¨ä¤¤ªü¥¬¬¥´À¥§ªº¨âºØ¾¯¶q§¡º¡¨¬¥Dn©M¦¸n²×ÂI¡C¦@¦P¥Dn²×ÂI«ü¼Ð¥]¬A¡GÀò±o½Õ¬dûªº¾ãÅéµû¦ô¡]IGA¡^¤À¼Æ¬°0©Î1¡]²M´·©Î¤j³¡¤À²M´·¡^¥B§ïµ½¤F2өΧó¦h¤Àªº¨ü¸ÕªÌ¤ñ¨Ò¡A¥H¤ÎÀò±o75¢Hªº§ïµ½ªº¨ü¸ÕªÌ¤ñ¨ÒÀã¯l±¿n©MÄY«µ{«×«ü¼Æ¡]EASI-75¡^¡C¦¸n²×ÂI¬O¤@©w¤ñ¨Òªº¨ü¸ÕªÌ¡A¨äæ±Äo¯g¼Æ¦rµû¤À¶qªí¡]NRS¡^°§C¤F¥|¤À©Î¥H¤W¡A¯SÀ³©Ê¥Öª¢ªºæ±Äo¯g©M¯gª¬µû¦ôªº°§C¶q¯Å¡]PSAAD¡^¡C¦b¦w¥þ©Ê¤è±¡Aªü¥¬¦è´À¥§100mg©M200mg¾¯¶q²Õªº°±ÃIJv§¡¬°5.8¢H¡A¦Ó¦w¼¢¾¯²Õ¬°9.1¢H¡C ±µ¨üGlobalDataªº¡§¯SÀ³©Ê¥Öª¢-2027¦~¥«³õ¤ÀªR©M¹w´ú¡¨³ø§i±Ä³Xªº¥Dn·N¨£»â³S¡]KOLs¡^¹ï³oºØÃĪ««ùªÖ©wºA«×¡A¤j¦h¼Æ¤H§Æ±æ¹ï¤¤¦Ü««×ªº¯SÀ³©Ê¥Öª¢±wªÌ¶i¦æ¦³®Äªº¤fªAªvÀø¡C¦¹¥~¡A¾¨ºÞ¤@¨ÇKOL¥ý«e¤w¹ïJAK§í»s¾¯¦b»·³Bªýꪢ¯g«H¸¹Âà¾Éªº¥þ¨§@¥Îªí¥Ü¾á¼~¡A¦ý³o¨Ç·sªñ¤½§Gªº¬ã¨sµ²ªG±N¦³§U©ó´î»´¤H̹ïªü¥¬¦è´À¥§¦w¥þ©Êªº¾á¼~¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/30 ¤W¤È 06:31:32²Ä 4841 ½g¦^À³
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KHK4083 15.2»õ¬ü¤¸vs Lebrikiumab 20»õ¬ü¤¸ ¥þ²y±ÂÅvª÷»ùÈ A/B=15.2»õ¬ü¤¸/20»õ¬ü¤¸¡C =66% ¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K ¤@¡B¤é¥»ÄQÅï±ÂÅv¦w¶iKHK4083 ¤é¥»ÄQÅ綠¥q2021/06±ÂÅvKHK4083 给¦w¶i¡A°£¤é¥»¥~¥þ²y¾P°âÅv¡C¤T´Á¦¨¥»¦ô4»õ¬ü¤¸¡A¦U¥b¡A ±ÂÅv¦X约=4»õ¬ü¤¸«eª÷+2»õ¬ü¤¸¤T´Á¦¨¥»+8.5»õ¬ü¤¸ùµ{ª÷+¾P°â¤À¼í 14.5»õ¬ü¤¸±ÂÅvª÷/«D¤é¥»95%=15.2»õ¬ü¤¸¡K¡K¾ãÅéKHK4083»ùÈ¡K¡KA ¤G¡B®Ú¾ÚLebrikiumab³Q±ÂÅvAlmirall ¦X约 ¡K¡KCEO«ÅºÙ欧¬w区AD³Ì°ª¥i¾P5»õ¬ü¤¸¡C ¡K¡K«eª÷+¶}µoùµ{ª÷1.98»õ¬ü¤¸+12.5»õ¬ü¤¸¡A³Ì°ª¾P°âùµ{ª÷(30»õ¬ü¤¸³Ì°ª¾P°â) +¾P°â¤À¼í10%-20% ±ÂÅvª÷1.98+2.1(5/30*12.5¡K¡K5»õ¬ü¤¸销°â°ò¦)¡A约4»õ¬ü¤¸¡C 4»õ¬ü¤¸/20%(欧¬w区)=20»õ¬ü¤¸¡K¡K¾ãÅéLebrikiumab±ÂÅvª÷AD»ùÈ¡K¡KB Lebrikizumab ¼Ú¬w°Ï±ÂÅv¦X¬ù(2019/02) www.sec.gov/edgar/search/?r=el#/q=Dermira ùµ{ª÷(1)3000+(1.1)5000+(2)3000+(3)4000+(4)4500=19,500(¸U¬ü¤¸) +(5)®ÚÕulebrikizumab¦b欧¬wªº¦~净销°â额达¨ì8600ÉE¬ü¤¸¦Ü30亿¬ü¤¸ªº¬Y¨Ç门槛¡A ¤ä¥I³Ì¦h12.5亿¬ü¤¸ªº´Ú项¡A¨C笔ýͦbªº¨½µ{¸O¦¡¥I´Ú约¥eÓì¥Î净销°â额门槛ªº7%¦Ü15%¡F¥H¤Î ¾P°â¤À¼í(6)°ò¤_欧¬wlebrikizumab¦~净销°â额¬Û应S围ªº层级¦Ê¤À¤ñS围ªº¯S许权¨Ï¥Î费¤ä¥I¡A¨ä¤¤²Ä¤@¦~净销°â额层级ªº¦Ê¤À¤ñ从§C两¦ì数开©l¡A³Ì°ª净销°â额层级ªº¦Ê¤À¤ñ¼W¥[¨ì§C¤G¤Q¦ì数¡C ®ÚÕu该协议¡AAlmirall将对Dermira©Óü®¥H¤U¥I´Úúå务¡C (1)3,000ÉE¬ü¤¸ªº´Á权费¡A¦b¥Í®Ä¤é´Á¦Z¼w¦Ì©Ô¥æ¥I该ª÷额ªº发²¼¦Z¤Q¡]10¡^个¤u§@¤é内¤ä¥I¡C (1.1)¦pªGAlmirall¦b¦¬¨ì数Õu¥]©M开发计¦E¦Zªº45¤Ñ内¦æ¨Ï¨ä选择权¥H获±o许¥i证¡A则应¤ä¥I5,000ÉE¬ü¤¸ªº选择权¦æ¨Ï费¡A该费¥Î应¦bDermira¦b选择权¦æ¨Ï¦Z¥æ¥I该ª÷额ªº发²¼¦Z¤Q¡]10¡^个¤u§@¤é内¤ä¥I¡C (2)¼w¦Ì©ÔûD动¬Y¨Ç3´Á临§É¬ã¨s¡]¨C项§¡为 3´Á试验¡^¡A¥i额¥~获±o3000ÉE¬ü¤¸¡A¨C项试验¦b达¨ì该¨½µ{¸O¦Z¤G¤Q¤¡]25¡^¤Ñ内¤ä¥I¡C (3)Almirall实现¬Y¨Ç监ºÞ¨½µ{¸O¦Z¡A¥i额¥~获±o4,000ÉE¬ü¤¸¡A¨C笔´Ú项§¡应¦b实现该¨½µ{¸O¦Z¼w¦Ì©Ô¥æ¥I发²¼¦Z¤G¤Q¤(25)¤Ñ内¤ä¥I¡C (4)¦b欧·ùº¦¸°Ó业¤Æ销°âlebrikizumab¦Z¡A获±o4500ÉE¬ü¤¸ªº¦¬¤J¡C (5)®ÚÕulebrikizumab¦b欧¬wªº¦~净销°â额达¨ì8600ÉE¬ü¤¸¦Ü30亿¬ü¤¸ªº¬Y¨Ç门槛¡A¤ä¥I³Ì¦h12.5亿¬ü¤¸ªº´Ú项¡A¨C笔ýͦbªº¨½µ{¸O¦¡¥I´Ú约¥eÓì¥Î净销°â额门槛ªº7%¦Ü15%¡F¥H¤Î (6)°ò¤_欧¬wlebrikizumab¦~净销°â额¬Û应S围ªº层级¦Ê¤À¤ñS围ªº¯S许权¨Ï¥Î费¤ä¥I¡A¨ä¤¤²Ä¤@¦~净销°â额层级ªº¦Ê¤À¤ñ从§C两¦ì数开©l¡A³Ì°ª净销°â额层级ªº¦Ê¤À¤ñ¼W¦Ü20% |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/29 ¤U¤È 12:18:15²Ä 4840 ½g¦^À³
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¬Ý°_¨Ó«D¶Ç²ÎAD(«DIL4/IL13 MOA ) §ó¹³OX40 ,KHK4083 ¥i¯à¬O¥t¥~«n¨¤¦â. Dupilumab+KHK4083 ,¦ô¥i±o³Ì¨ÎªvÀø®ÄªG. IL22 ¨Ì¤U¹Ï¬Ý³Q OX40 ,KHK4083 ©Ò¥]§t, ir.kyowakirin.com/en/library/events/main/03/teaserItems1/0/linkList/00/link/181203_02_KHK4083_en.pdf p.3 T1/2/17/22--T ²ÓM VS AD Ãö³s¹Ï, 2015 ´Á¥Z ¥æ¥N¦hºØ·sÃÄMOA. IL22 2016¦~, ILV-094³æ§Ü2aÁ{§É 60¤H,Á{§É¥Dn«ü¼ÐEASI¥§¡°´T©M¹ï·Ó²ÕµL®t²§.---- |
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·|û¡G§d½n¶¯10142119 µoªí®É¶¡:2021/10/29 ¤U¤È 12:10:53²Ä 4839 ½g¦^À³
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ad¦¨¦]«D±`½ÆÂø¡A¨S¦³¤@ºØÃĪ«¬O100¢H¦³®Äªº¡A¥Ø«e¬Ý¨ìªº¦U¶µ¹êÅç¡A¦ü¥G¤]¨S¦³¤@ºØÃĪ«¡A¥i¥H¡uªv¡¡v³o¶µ¯e¯f ¦bªø´ÁªºªvÀø¨Ï¥ÎÃĪ«ªº¹Lµ{¤¤¡AÃĪ«ªº®Ä¤O¡B°Æ§@¥Î¡B¥ÎÃĪº¤è«K©Ê¡B»ù®æ¡B³£¬On¯Ç¤J¦Ò¶qªº¡A ox40¤w¸g¦³´XÓÃĪ«¦b¶}µo¤¤¡A·à¤l2b¯uªº±on¦n¦n³W¹º¡A®³¥Xº}«Gªº¼Æ¾Ú¤~¦æ |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/29 ¤W¤È 11:56:51²Ä 4838 ½g¦^À³
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Randomized Placebo Controlled Study to Determine Safety, Pharmacodynamics and Efficacy of ILV-094 in Atopic Dermatitis N=40+20 *12¶g Detailed Description: This is a randomized, double-blind, placebo-controlled, study of six IV infusions of ILV-094 administered to subjects with atopic dermatitis. Sixty subjects will be randomly assigned in a 2:1 ratio to one of the two treatments arms (ILV-094 vs placebo). Forty patients will be enrolled in the ILV-094 treatment arm and 20 in the placebo-treatment arm, accordingly. A loading IV dose of 600 mg of ILV-094 or placebo will be given at baseline (Day 0), followed by five additional IV doses of 300 mg of ILV-094 or placebo every two weeks (Weeks 2, 4, 6, 8, and 10). We will continue to follow the patients every two weeks for an additional 10 weeks after the last IV dose (20 weeks post baseline). fficial Title: A Randomized Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacodynamics and Clinical Efficacy of ILV-094 (an IL-22 Antibody) Administered Intravenously to Subjects With Atopic Dermatitis (AD) Actual Study Start Date : October 2013 Actual Primary Completion Date : February 2016 Actual Study Completion Date : January 2019 clinicaltrials.gov/ct2/show/study/NCT01941537 ¬ã¨sµ²ªG clinicaltrials.gov/ct2/show/results/NCT01941537 ¹êÅç²Õ 40¤H VS ¹ï·Ó²Õ 20 ¤H ¥Dn«ü¼Ð:12¶g EASI ¥§¡°´T: 18.8% VS 11.7% ,P =0.74 >0.05 (¤£¹LÃö) EASI50 22.2% VS 15% IGA 0.1 0.6% VS 0.3% ----------------------------------- IL22 2A ¥Dn«ü¼Ð没¹LÃö |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/29 ¤W¤È 11:36:19²Ä 4837 ½g¦^À³
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ir.kyowakirin.com/en/library/events/main/03/teaserItems1/0/linkList/00/link/181203_02_KHK4083_en.pdf p.3 T1/2/17/22--T ²ÓM VS AD Ãö³s¹Ï, 2015 ´Á¥Z ¥æ¥N¦hºØ·sÃÄMOA. IL22 ¤w¦³ ILV-094³æ§Ü¦bÁ{§É¹êÅ礤. |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/10/29 ¤W¤È 09:53:00²Ä 4836 ½g¦^À³
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AMGªºªÑ»ù¦ü¥G¨S¦³¦]KHK4083ªº¼Æ¾Ú³ø§i ¦³¤°»ò¼vÅT¡A¤Ï¦Ó¤p¶^¡A¬O¨S¤°»òÄvª§¤O¶Ü¡H |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/29 ¤W¤È 08:20:16²Ä 4835 ½g¦^À³
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·sªºM0A´N¦³¨ä»ùÈ¡A ¤é¥»ÃMÅ綠¥q2021/06±ÂÅvKHK4083 给¦w¶i¡A°£¤é¥»¥~¥þ²y¾P°âÅv¡C ¤T´Á¦¨¥»¦U¥b¡A ±ÂÅv¦X约=4»õ¬ü¤¸«eª÷+8.5»õùµ{ª÷+¾P°â¤À¼í ¤G´Á¥§¡EASI°´T约60%/¹ï·Ó组15%¥ª¥k¡A dupilumab 70%/34%¡C EASI75 ,¦©°£¹ï·Ó²Õ ¤é¥»骑Åï KHK4083 43% Dupilumab 36% ASLAN004 37% ý³Ý¡BCOPD¡K¡Kµ¥¬O§_¾A¥Î¡A©|µLÁ{§Éµý©ú¡C ¦ô 2029¦~¡A¤¤-««×AD¥«³õ290»õ¬ü¤¸¡A ¤µ¦~¥@¬É°ß¤@¤W¥«ªº¥Íª«»s¾¯±N½æ60¦h»õ¬ü¤¸(AD+ý³Ý¡K¡K)¡C ý³Ý¥Íª«»s¾¯¡A¥Ø«e¦~销约60»õ¬ü¤¸¡A¤w4ºØ·sÃĤW¥«¡C 2029¦~ ¤¤-««×AD 240»õ¬ü¤¸+¤¤-««×ý³Ý200»õ¬ü¤¸+¨ä¥L«¬IIª¢¯g¡A ¥Íª«»s¾¯¡A¦ôp¶W¹L500»õ¬ü¤¸¡C ¥þ²y·sÃĬã¨sªºµJÂI¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/29 ¤W¤È 07:11:24²Ä 4834 ½g¦^À³
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Amgen enters up to $1.2bn atopic dermatitis drug deal with Kyowa Kirin 02 Jun 2021 (Last Updated October 27th, 2021 11:40) Amgen will make an upfront payment of $400m to Kyowa Kirin and milestone payments worth up to nearly $850m. Share Article Amgen enters up to $1.2bn atopic dermatitis drug deal with Kyowa Kirin Amgen headquarters in Thousand Oaks, California, US. Credit: Coolcaesar / Wikipedia. Amgen and Kyowa Kirin have entered an agreement to co-develop and co-commercialise the latter¡¦s anti-OX40 fully human monoclonal antibody, KHK4083 to treat atopic dermatitis and potentially other autoimmune diseases. Discovered by Kyowa Kirin, KHK4083 demonstrated the ability to specifically reduce activated T cells that are vital in atopic dermatitis development. According to the deal, Amgen will handle the development, production and marketing of KHK4083 for all worldwide markets, excluding Japan. Kyowa Kirin will retain all rights in Japan. The partners will co-promote KHK4083 and Kyowa Kirin holds opt-in rights to co-promote the therapeutic in some other markets outside the US, including Europe and Asia. As part of this transaction, Kyowa Kirin will receive an upfront payment of $400m from Amgen and prospective contingent milestone payments up to worth $850m. Kyowa Kirin is also eligible to receive royalty payments emerging from worldwide sales. The global development costs, except in Japan, as well as US marketing costs, will be shared by the companies. Furthermore, Amgen plans to utilise data from the company¡¦s deCODE Genetics subsidiary to analyse the possible use of KHK4083 in therapy areas other than atopic dermatitis. KHK4083 is set for Phase III trials after Kyowa Kirin reported in February that the antibody met the primary goal in a Phase II trial in moderate-to-severe atopic dermatitis subjects. Kyowa Kirin president and CEO Masashi Miyamoto said: ¡§KHK4083 is an important asset in our global pipeline. ¡§We know Amgen well and this alliance will build on the past success and trust we have, bringing additional resources and therapeutic expertise to KHK4083¡¦s development and commercialisation, to meet the needs of patients living with atopic dermatitis who seek alternative treatment options.¡¨ ¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1¶ |
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·|û¡G¸Ø±i10133098 µoªí®É¶¡:2021/10/29 ¤W¤È 06:20:09²Ä 4833 ½g¦^À³
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AMG 451/KHK4083 «l¼Ä¥X²{? ½Ð¤Ñ©R¤j¤j¤ÀªRÀu¶Õ¦H±Ñ (AMG 451/KHK4083¦³°Æ§@¥Î) |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/28 ¤U¤È 10:04:14²Ä 4832 ½g¦^À³
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ir.aslanpharma.com/static-files/91b50c3a-8645-40d1-8ea7-e559d45956e6 10/25, KOL Supporting Materials, §ë¼v¤ù, P.22 Comparison of proof of concept studies in atopic dermatitis ¯SÀ³©Ê¥Öª¢·§©ÀÅçÃÒ¬ã¨sªº¤ñ¸û ---¬O§_¹F²Îp¤WÅãµÛ®t²§(<0.05) P.23 Efficacy of selected drugs in atopic dermatitis (placebo-adjusted EASI-75) at 16 weeks ¯S©wÃĪ«¦b 16 ¶g®É¹ï¯SÀ³©Ê¥Öª¢¡]¦w¼¢¾¯½Õ¾ãªº EASI-75¡^ªºÀø®Ä -(¹êÅç²Õ´î¥h¹ï·Ó²Õ¤§«áªºEASI75Àø®Ä) |
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·|û¡G«Ó°¶10144972 µoªí®É¶¡:2021/10/28 ¤W¤È 11:43:13²Ä 4831 ½g¦^À³
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«e´X¤Ñ±þ¨ì1.39¯}¤@¦~§CÂI1.42¯u¬O¤Ó¨¸´c ¨S«H¤ßªºÀ³¸Ó³£²æ¤â¤F ¯d¤U¦³«H¤ß©M¶^¨ì¸}³Âªº ©Ò¥Hµu½uÄw½X«D±`°®²b ¦pªG¤µ¤Ñ¦A¨Ó¸òªø¬õ´Î§CÂIÀ³¸Ó´N½T¥ß ¤j®a´N¥i¥H¼e¤ßµ¥©ú¦~2b¤F |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/28 ¤W¤È 08:44:46²Ä 4830 ½g¦^À³
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µØº¸µó¦bt³d¥]¾PASLN ·sªÑµo¦æ ¥L̤£·Ç.½Ö·Ç? ¤U¦¸¶Ò¸ê2B¤½§G¼Æ¾Ú, ¥Ø¼Ð»ù6~8¬ü¤¸ ¶]¤£±¼! n¶Ò¸ê¦A¨Ó©Ô»ù. ª½¨ì³Q¨ÖÁÊ,¤@»ù¨ì¦ì! H.C. Wainwright »{¬° Aslan Pharmaceuticals ªºªÑ²¼±N«ì´_ ³Í¸¦Åv¤O ³Í¸¦Åv¤O 2021 ¦~ 10 ¤ë 27 ¤é¤U¤È 06:28 ¤@ºØ ¤@ºØ ¦b¤µ¤Ñµo¥¬ªº¤@¥÷³ø§i¤¤¡A¨Ó¦Û H.C. Wainwright «¥Ó¤F¹ï Aslan Pharmaceuticals¡]ASLN ¡V ¬ã¨s³ø§i¡^ªº¶R¤Jµû¯Å¡A¥Ø¼Ð»ù¬° 8.00 ¬ü¤¸¡C¸Ó¤½¥qªÑ»ù¤W¶g¤G¦¬©ó 1.52 ¬ü¤¸¡A±µªñ 1.38 ¬ü¤¸ªº 52 ¶g§CÂI¡C ®Ú¾Ú TipRanks.com ªº¼Æ¾Ú¡A³¯¬O¤@¦W 5 ¬P¯Å¤ÀªR®v¡A¥§¡¦^³ø²v¬° 45.0%¡A¦¨¥\²v¬° 46.3%¡C Chen ²[»\ÂåÀø«O°·¦æ·~¡A«ÂIÃöª` Ortho Clinical Diagnostics Holdings¡BInterpace Diagnostics Group ©M HTG Molecular Diagnostics µ¥ªÑ²¼¡C µØº¸µóªºÁ`Åé®ø®§ªí©ú¡A¤ÀªR®v¹ï Aslan Pharmaceuticals ªº¦@Ãѵû¯Å¬°·Å©M¶R¤J¡A¥§¡¥Ø¼Ð»ù¬° 8.00 ¬ü¤¸¡C ¬d¬Ý¤ÀªR®v±ÀÂ˪º³»¯ÅªÑ²¼>> H.C. Wainwright Thinks Aslan Pharmaceuticals¡¦ Stock is Going to Recover Catie Powers Catie Powers Oct 27, 2021, 06:28 PM In a report released today, Yi Chen from H.C. Wainwright reiterated a Buy rating on Aslan Pharmaceuticals (ASLN ¡V Research Report), with a price target of $8.00. The company¡¦s shares closed last Tuesday at $1.52, close to its 52-week low of $1.38. According to TipRanks.com, Chen is a 5-star analyst with an average return of 45.0% and a 46.3% success rate. Chen covers the Healthcare sector, focusing on stocks such as Ortho Clinical Diagnostics Holdings, Interpace Diagnostics Group, and HTG Molecular Diagnostics. The word on The Street in general, suggests a Moderate Buy analyst consensus rating for Aslan Pharmaceuticals with a $8.00 average price target. |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/10/28 ¤W¤È 08:27:24²Ä 4829 ½g¦^À³
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µØº¸µó³o¨Ç¦º¥Õ¤ò¡AªGµM±þ¤H¡AÁÙn¸Ý¤ß Ó¤Hı±o³Å«iªº½Í§P¡AÄw¸ê¡A²£·~ªº¤H¯ß ¥@¬É¬×ªºÁ{§É§G§½³£«Ü¦³¹ê¤O ³Ñ¤UªºÀ³¸Ó»EµJ©ó003¡A004ªºÀø®Ä´N¦æ¤F ¦Ü©ó¤½¥q´£¨ìªº·ÀI³¡¤À¡A¤]³£¬O¤j®a±`°Q½×ªº °ÝÃD µ²½× ¤p´I¥Ñ»ü¡A¤j´I¥Ñ¤Ñ nÁȨì¤j¿ú¡AÁٽЦѤÑÀ°¦£ |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/27 ¤U¤È 09:05:49²Ä 4828 ½g¦^À³
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Dupilumab 2Ó¤T´Á *16¶g*300mg,¹êÅç²Õ N=900¤H ¤@.¤À²Õ&ITT¤ÀªR 1.¤¤Â_ ,¹êÅç²Õ 6.3% EASI 50 , 0% EASI 75 , 0% EASI 90 , 0% IGA 0,1 , 0% 2.¦©°£ ¤¤Â_6.3%¤H¼Æ«á ¹êÅç²Õ 93.7%¤H¼Æ EASI 50 , 68% EASI 75 , 52% EASI 90 , 35% IGA 0,1 , 39% 3.ITT ,100%¤H¼Æ(¬ù900¤H) EASI 50 , 64% EASI 75 , 49% EASI 90 , 33% IGA 0,1 , 37% |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/27 ¤U¤È 08:23:51²Ä 4827 ½g¦^À³
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ASLAN004 1b *8¶g*600mg ¤@.¤À²Õ&ITT¤ÀªR 1.3/1«e 600mg ¹êÅç²Õ 3¤H EASI 50 , 100%(3/3) EASI 75 , 67%(2/3) EASI 90 , 33%(1/3) IGA 0,1 , 33% (1/3) 2.3/1«á 600mg ¹êÅç²Õ 10¤H EASI 50 , 100%(10/10) EASI 75 , 90%(9/10) EASI 90 , 50%(5/10) IGA 0,1 , 60%(6/10) 3.¥H¤W¦b¤ÀªRASLAN004¯u¥¿¯à¤O.(¤w¦©°£«D¶Ç²ÎAD 6¤H¡B¤¤Â_3¤H ¼vÅT) 4.«D¶Ç²ÎAD 6¤H EASI 50 , 66%(4/6) EASI 75 , 0%(0/6) EASI 90 , 0%(0/6) IGA 0,1 , 0%(0/6) 5.¤¤Â_3¤H EASI 50 , 0%(0/3) EASI 75 , 0%(0/3) EASI 90 , 0%(0/3) IGA 0,1 , 0%(0/3) 6.¥»¦¸ITT¤ÀªR ,¨ü«D¶Ç²ÎAD6¤H¡B¤¤Â_3¤H ,9(3+6)/22=41%¼vÅT. EASI 50 , 77%(17/22) EASI 75 , 50%(11/22) EASI 90 , 27%(6/22) IGA 0,1 , 32%(7/22) ----------------------------------------------------- ------------ ¤G.2b ±N±´¯ÁIL22 .ASLAN004 ,2b ,300¤H,±N±´¯ÁIL22 ¬O§_·|¼vÅTÀø®Ä. ¬O§_¬°«D¶Ç²ÎADªº¥Dn¼vÅT¦]¯À. ¦p¶Ý»Ä©Ê²ÓM<150/ml,¥Îdupilumab ªvý³ÝµL®Ä, «D¶Ç²ÎAD,¥Ø«eDupilumab/Lebrikiumab/Traloikumab ¥ç©M¹ï·Ó²ÕµL®t²§.¦]¬°¤£¬OIL4/IL13©Ò¤Þ°_¤§¾÷¨î. |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/27 ¤U¤È 07:27:21²Ä 4826 ½g¦^À³
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¤T¡BLebrikizumab & Tralokinumab MOA ¥u¯àªýÂ_IL13 °T¸¹¶Ç»¼¡AµLªk§¹¥þªýÂ_IL4 °T¸¹¶Ç»¼¡A¥\¯à¤j´î75%~50%¡C µLªkªýÂ_ A¸ô®| (2): IL4 & IL-4R£\ ¦A±µ¦XIL-13R£\1 , ²Õ¦¨ªºII«¬¨üÅé, ¦]¦Ó±Ò°Ê²ÓM¤ºªº«H¸¹¶Ç»¼¡A¶i¦Ó¬¡¤ÆÂà¿ý¿E¬¡³J¥Õ6 (signal transducer and activator of transcription 6, STAT6) ¶Ç¾É¸ô®|,¾ÉP¹L±Ó©Êµoª¢¤ÏÀ³¡C ¥u¯àªýÂ_B¸ô®| : Lebrikizumab ±µ¦X IL13 ªºB¡BCÁ³±Û , ¦ýIL13 & IL-13R£\1 ¤´¥i±µ¦X¡A¥u¬OµLªk¦A±µ¦X IL-4 R£\,µLªk²Õ¦¨ II«¬ ¨üÅé Tralokinumab ±µ¦XIL13 ªºA¡BDÁ³±Û ¨Ï IL13 & IL-13R£\1 µLªk±µ¦X¡A¤]µLªk¦A±µ¦X IL-4 R£\,µLªk²Õ¦¨ II «¬¨üÅé ¥H¤W¸ÑÄÀ Tralokinumab ¤T´ÁÁ{§É¹w«á«ü¼Ð¡AÀø®Ä´X¥G¥u¦³Dupilumab 50%¡C ¦]Lebrikizumab , IL13 & IL-13R£\1 ¤´¥i±µ¦X¦û¾Ú IL-13R £\1, ¼vÅT0~50% IL4 °T¸¹¶Ç»¼¡C ¤]¸ÑÄÀ Lebrikizumab ¤G´ÁÁ{§É¹w«á¥Dn«ü¼Ð»P¹ï·Ó²Õ¤ñ È ¥u¦³Dupilumab 50%~75%¡C |
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/27 ¤U¤È 07:12:57²Ä 4825 ½g¦^À³
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2020,2¤ë¡ALebrikiumab°µ§¹AD ,2bÁ{§É ªºDERM¤½¥q ,°µ§¹2b,´N½æ11»õ¬ü¤¸¡C 11/50*120*2=53»õ¬ü¤¸¡C(¥Ø«e¤@»õ¬ü¤¸¥«È) ®t53¿¡C Àø®Ä ASLAN004>dupilumab ¼Ð·ÇÀøªk> 0.75 Lebrikiumab ¦]结½¤ª¢¬G¡Adupilumab µLªk¶g¡B¶g¥Î600mg«¾¯¶q¡C Lebrikiumab ¶È¯à³¡¥÷«Ê¦íIL4. 2016/02 °µ§¹1/2´ÁIMMU ÀòBTD¡AªÑ»ù2.36¬ü¤¸¡C ¨ÖÁÊ»ù87¬ü¤¸¡A2020/09 87/2.36=37¿¡C ¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K¡K ´N½ä¨ÖÁÊ¡I |
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ASLAN 9¤ë30¤é¤î,±b¤W²{ª÷¤Î²{ª÷µ¥»ùª«Á`ÃB¬° 1 »õ¬ü¤¸¡A ºÞ²z¼h»{¬°¨È·à±dªº²{ª÷¤Î²{ª÷µ¥»ùª«±N¨¬¥H °òª÷¹BÀç¨ì 2023 ¦~©³ ----------------------------------------------------------------------- ºI¦Ü 2021 ¦~ 9 ¤ë 30 ¤é¡A²{ª÷¤Î²{ª÷µ¥»ùª«Á`ÃB¬° 1.005 »õ¬ü¤¸¡A ºI¦Ü 2021 ¦~ 6 ¤ë 30 ¤é¬° 9,410 ¸U¬ü¤¸¡A ºI¦Ü 2020 ¦~ 12 ¤ë 31 ¤é¬° 1,430 ¸U¬ü¤¸¡C ºÞ²z¼h»{¬°¨È·à±dªº²{ª÷¤Î²{ª÷µ¥»ùª«±N¨¬¥H °òª÷¹BÀç¨ì 2023 ¦~©³¡C 7 ¤ë¡AASLAN »P K2 HealthVentures Àò±o¤F°ª¹F 4500 ¸U¬ü¤¸ªº¾á«O¶Å°È¿Ä¸êªº¶U´Ú¦w±Æ¡C ¸Ó¿Ä¸ê¥]¬A¦b¥æ©ö§¹¦¨®É´£¨Ñªº 2,000 ¸U¬ü¤¸ªì©l©w´Á¶U´Ú¡A ¨ä¾l 2,500 ¸U¬ü¤¸¨ü¬Y¨Ç±ø´Ú©M±ø¥óªº¬ù§ô¡C ©Ò±o´Ú¶µ±N¥Î©ó±À¶i ASLAN003ªºÁ{§É¶}µo¥H¤Î¤@¯ë¤½¥q¥Î³~¡C -------------------------------------------------------------------------------- ¦bpºâ 2021 ¦~²Ä¤T©u«×¨CªÑ°ò¥»Á«·l®É¡A ¤wµo¦æ ADS ªº¥[Åv¥§¡¼Æ¬° 6,970 ¸UªÑ¡]¥Nªí 3.48 »õªÑ´¶³qªÑ¡^¡A ¦Ó 2020 ¦~²Ä¤T©u«×¬° 3,800 ¸UªÑ¡]¥Nªí 1.9 »õªÑ´¶³qªÑ¡^¡C ¤@ ADS ¬Û·í©ó¤ªÑ´¶³qªÑ¡C ir.aslanpharma.com/news-releases/news-release-details/aslan-pharmaceuticals-reports-third-quarter-2021-financial Cash and cash equivalents totalled US$100.5 million as of September 30, 2021, compared to US$94.1 million as of June 30, 2021, and US$14.3 million as of December 31, 2020. Management believes that ASLAN¡¦s cash and cash equivalents will be sufficient to fund operations through late 2023. In July, ASLAN secured a loan facility with K2 HealthVentures of up to US$45.0 million of secured debt financing. The facility consists of a US$20.0 million initial term loan funded at closing, with the remaining US$25.0 million subject to certain terms and conditions. The proceeds will be used to advance the clinical development of ASLAN003 as well as for general corporate purposes. The weighted average number of ADSs outstanding in the computation of basic loss per share for the third quarter of 2021 was 69.7 million (representing 348 million ordinary shares) compared to 38.0 million (representing 190 million ordinary shares) for the third quarter of 2020. One ADS is the equivalent of five ordinary shares. |
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·|û¡G¦N¦Ì10148522 µoªí®É¶¡:2021/10/27 ¤W¤È 08:41:43²Ä 4821 ½g¦^À³
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·|û¡G¤Ñ©R10141925 µoªí®É¶¡:2021/10/26 ¤U¤È 09:53:47²Ä 4820 ½g¦^À³
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ir.aslanpharma.com/news-releases/news-release-details/aslan-pharmaceuticals-reports-third-quarter-2021-financial Oct 26,2021 ASLAN Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Corporate Update |
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·|û¡G¬õ¹Ð¦³¹Ú10150039 µoªí®É¶¡:2021/10/26 ¤U¤È 04:41:10²Ä 4819 ½g¦^À³
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